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Subcutaneous ICD (S-ICD) system

A defibrillator system that FDA approved in September 2012 as a subcutaneous (under-the-skin) implantable defibrillator, the S-ICD. The approval order, addressed to Cameron Health, Inc., says it is meant to give shock therapy for life-threatening fast ventricular rhythms in patients who have none of these: ventricular tachycardia that is incessant; slow heart rhythm with symptoms (symptomatic bradycardia); or ventricular tachycardia that recurs often, starts on its own and is reliably ended by antitachycardia pacing. FDA's summary describes an electrode designed to be tunneled under the skin from the pocket that holds the pulse generator to near the lower tip of the breastbone, in contrast to transvenous leads. Sale is limited to prescription use.

Also called S-ICD

  • Product
  • In this atlas

Overview

Technical summary

FDA premarket approval P110042, decided 2012-09-28 (received 2011-12-23), procodes LWS and NVY, device class 3, expedited review flag Y. The approval order of 2012-09-28 is addressed to Cameron Health, Inc., and the summary of safety and effectiveness names Cameron Health, Inc. as applicant; the openFDA record now lists Boston Scientific Corporation as the applicant. The 2012 system is the pulse generator (SQ-RX Model 1010), the subcutaneous electrode (Q-TRAK Model 3010), the programmer (Q-TECH Model 2020) and the electrode insertion tool (Q-GUIDE Model 4010). The openFDA data hold 207 records for P110042, the original approval and its supplements, including newer models; this page covers the original approval only. The approval statement is printed in capitals in openFDA and reads INPATIENTS as one word. The openFDA registration and listing records name Boston Scientific Corporation entities as manufacturing establishments for the P110042 devices; that listing is current and does not show who made the first device in 2012.

Product details

Type
Device
Model or formulation
Cameron Health Subcutaneous Implantable Defibrillator S-ICD System, as the FDA summary names it (trade name in openFDA: SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM)
Version
Original approval P110042 (2012): SQ-RX Model 1010 pulse generator, Q-TRAK Model 3010 subcutaneous electrode, Q-TECH Model 2020 programmer and Q-GUIDE Model 4010 electrode insertion tool. Later supplements, including newer models, are not described here.

Intended-use sources

  1. Background FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)

    Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 207 openFDA PMA records for P110042 by decision date (2012-09-28), taken as the original approval. The later records are supplements, including newer models, and are not described here. · PMA: P110042

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c
    Reuse basis
    openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P110042.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

  2. Background FDA summary of safety and effectiveness data for PMA P110042 (S-ICD system)

    Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext.

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    8a052560d1cc4bc0195cef255be69a40c02be986894204fba85a5be0eb2402b9
    Reuse basis
    FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-p110042-ssed.pdf).

Claims and evidence

Context United States premarket approval P110042 for the subcutaneous implantable defibrillator system (S-ICD)

Recipient
Recipient not specified
Population
Patients who need shock therapy for life-threatening fast ventricular rhythms and who have none of these: ventricular tachycardia that is incessant; slow heart rhythm with symptoms (symptomatic bradycardia); or ventricular tachycardia that recurs often, starts on its own and is reliably ended by antitachycardia pacing (restated from the approval order and the openFDA statement, which reads "INPATIENTS").
Care setting
Not stated in the FDA record.
Geography
United States (decision by the US Food and Drug Administration).
Life stage
Not stated in the FDA record (it gives no age).
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory decision).
Eligibility: 1 inclusion criterion; 3 exclusion criteria
Included
  • Life-threatening fast ventricular rhythms needing shock therapy
Excluded
  • Slow heart rhythm with symptoms (symptomatic bradycardia)
  • Ventricular tachycardia that is incessant
  • Ventricular tachycardia that recurs often, starts on its own and is reliably ended by antitachycardia pacing

  • Regulatory Evidence stage not applicable Certainty not assessed

    The US Food and Drug Administration approved premarket approval application P110042 for a subcutaneous implantable defibrillator system on 28 September 2012. The approval order, dated that day, is addressed to Cameron Health, Inc. of San Clemente, California, and lists the procodes LWS and NVY. The summary of safety and effectiveness names Cameron Health, Inc. as the applicant and describes the system as the pulse generator (SQ-RX Model 1010), the subcutaneous electrode (Q-TRAK Model 3010), the programmer (Q-TECH Model 2020) and the electrode insertion tool (Q-GUIDE Model 4010). The openFDA record, which gives the receipt of the application on 23 December 2011, product code LWS, device class 3 and an expedited review flag of Y, now names Boston Scientific Corporation as the applicant; that field holds the current holder. The approval order and the openFDA approval-order statement (printed in capitals, with the word "INPATIENTS" run together, which is taken here to mean in patients) say the system is meant to give shock therapy for life-threatening fast ventricular rhythms in patients who have none of these: ventricular tachycardia that is incessant; slow heart rhythm with symptoms (symptomatic bradycardia); or ventricular tachycardia that recurs often, starts on its own and is reliably ended by antitachycardia pacing. The order limits sale and distribution to prescription use. The summary of safety and effectiveness describes an electrode designed to be tunneled under the skin from the pocket that holds the pulse generator to a cut near the lower tip of the breastbone, in contrast to transvenous leads.

    Applies to Recipient not specified
    • Patients who need shock therapy for life-threatening fast ventricular rhythms and who have none of these: ventricular tachycardia that is incessant; slow heart rhythm with symptoms (symptomatic bradycardia); or ventricular tachycardia that recurs often, starts on its own and is reliably ended by antitachycardia pacing (restated from the approval order and the openFDA statement, which reads "INPATIENTS").
    • Not stated in the FDA record.
    • United States (decision by the US Food and Drug Administration).
    • Not stated in the FDA record (it gives no age).
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision).
    Certainty method
    Not assessed
    Limitations
    This is the original approval. The openFDA data hold 207 records for P110042, the original and its supplements, including newer models, which are not described here. The approval statement sets who the device is intended for; it does not state that it improves survival or compares it with other defibrillators. The FDA documents are cite-only here, so their wording is restated and not quoted. openFDA data are unvalidated, and its own disclaimer says not to rely on them for medical decisions. The decision's indication text restates the openFDA approval-order statement in the atlas's own words; the statement is printed in capitals and one word is run together, as the claim statement notes.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (23)

    1. Supports FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 207 openFDA PMA records for P110042 by decision date (2012-09-28), taken as the original approval. The later records are supplements, including newer models, and are not described here. · PMA: P110042

      Locator
      results[0].pma_number
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P110042.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    2. Supports FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 207 openFDA PMA records for P110042 by decision date (2012-09-28), taken as the original approval. The later records are supplements, including newer models, and are not described here. · PMA: P110042

      Locator
      results[0].applicant
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P110042.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    3. Supports FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 207 openFDA PMA records for P110042 by decision date (2012-09-28), taken as the original approval. The later records are supplements, including newer models, and are not described here. · PMA: P110042

      Locator
      results[0].trade_name
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P110042.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    4. Supports FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 207 openFDA PMA records for P110042 by decision date (2012-09-28), taken as the original approval. The later records are supplements, including newer models, and are not described here. · PMA: P110042

      Locator
      results[0].generic_name
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P110042.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    5. Supports FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 207 openFDA PMA records for P110042 by decision date (2012-09-28), taken as the original approval. The later records are supplements, including newer models, and are not described here. · PMA: P110042

      Locator
      results[0].product_code
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P110042.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    6. Supports FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 207 openFDA PMA records for P110042 by decision date (2012-09-28), taken as the original approval. The later records are supplements, including newer models, and are not described here. · PMA: P110042

      Locator
      results[0].decision_date
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P110042.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    7. Supports FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 207 openFDA PMA records for P110042 by decision date (2012-09-28), taken as the original approval. The later records are supplements, including newer models, and are not described here. · PMA: P110042

      Locator
      results[0].date_received
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P110042.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    8. Supports FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 207 openFDA PMA records for P110042 by decision date (2012-09-28), taken as the original approval. The later records are supplements, including newer models, and are not described here. · PMA: P110042

      Locator
      results[0].decision_code
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P110042.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    9. Supports FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 207 openFDA PMA records for P110042 by decision date (2012-09-28), taken as the original approval. The later records are supplements, including newer models, and are not described here. · PMA: P110042

      Locator
      results[0].openfda.device_class
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P110042.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    10. Supports FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 207 openFDA PMA records for P110042 by decision date (2012-09-28), taken as the original approval. The later records are supplements, including newer models, and are not described here. · PMA: P110042

      Locator
      results[0].expedited_review_flag
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P110042.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    11. Supports FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 207 openFDA PMA records for P110042 by decision date (2012-09-28), taken as the original approval. The later records are supplements, including newer models, and are not described here. · PMA: P110042

      Locator
      results[0].ao_statement (fragment 1 of 4)
      How it applies
      Approval-order statement, as openFDA prints it (fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P110042.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    12. Supports FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 207 openFDA PMA records for P110042 by decision date (2012-09-28), taken as the original approval. The later records are supplements, including newer models, and are not described here. · PMA: P110042

      Locator
      results[0].ao_statement (fragment 2 of 4)
      How it applies
      Approval-order statement, as openFDA prints it (fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P110042.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    13. Supports FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 207 openFDA PMA records for P110042 by decision date (2012-09-28), taken as the original approval. The later records are supplements, including newer models, and are not described here. · PMA: P110042

      Locator
      results[0].ao_statement (fragment 3 of 4)
      How it applies
      Approval-order statement, as openFDA prints it (fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P110042.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    14. Supports FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 207 openFDA PMA records for P110042 by decision date (2012-09-28), taken as the original approval. The later records are supplements, including newer models, and are not described here. · PMA: P110042

      Locator
      results[0].ao_statement (fragment 4 of 4)
      How it applies
      Approval-order statement, as openFDA prints it (fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P110042.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    15. Background FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 207 openFDA PMA records for P110042 by decision date (2012-09-28), taken as the original approval. The later records are supplements, including newer models, and are not described here. · PMA: P110042

      Locator
      meta.disclaimer
      How it applies
      openFDA's own disclaimer about relying on its data.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P110042.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    16. Supports FDA approval order for PMA P110042 (subcutaneous implantable defibrillator system, 28 September 2012)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The text layer is imperfect in places, so only short lines are quoted.

      Locator
      Page 1, addressee
      How it applies
      Statement in the cited record.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      aa5df2300ea5f2a6ccf140de6baa28eb0d38b277d6b90ddbcc3eea88bf6cd862
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-p110042-order.pdf).

    17. Supports FDA approval order for PMA P110042 (subcutaneous implantable defibrillator system, 28 September 2012)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The text layer is imperfect in places, so only short lines are quoted.

      Locator
      Page 1, date line
      How it applies
      Statement in the cited record.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
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      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-p110042-order.pdf).

    18. Supports FDA approval order for PMA P110042 (subcutaneous implantable defibrillator system, 28 September 2012)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The text layer is imperfect in places, so only short lines are quoted.

      Locator
      Page 1, Re: line
      How it applies
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      Current
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      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-p110042-order.pdf).

    19. Supports FDA approval order for PMA P110042 (subcutaneous implantable defibrillator system, 28 September 2012)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The text layer is imperfect in places, so only short lines are quoted.

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      Page 1, sale and distribution
      How it applies
      Statement in the cited record.
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      Source effective date
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      aa5df2300ea5f2a6ccf140de6baa28eb0d38b277d6b90ddbcc3eea88bf6cd862
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      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-p110042-order.pdf).

    20. Supports FDA summary of safety and effectiveness data for PMA P110042 (S-ICD system)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext.

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      Section I, general information
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      8a052560d1cc4bc0195cef255be69a40c02be986894204fba85a5be0eb2402b9
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      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-p110042-ssed.pdf).

    21. Supports FDA summary of safety and effectiveness data for PMA P110042 (S-ICD system)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext.

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      Section I, device trade name
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      Statement in the cited record.
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      8a052560d1cc4bc0195cef255be69a40c02be986894204fba85a5be0eb2402b9
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    22. Supports FDA summary of safety and effectiveness data for PMA P110042 (S-ICD system)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext.

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    23. Supports FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 207 openFDA PMA records for P110042 by decision date (2012-09-28), taken as the original approval. The later records are supplements, including newer models, and are not described here. · PMA: P110042

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Authorization

Regulatory decision: Subcutaneous ICD (S-ICD) system

Applies to Recipient not specified
  • Patients who need shock therapy for life-threatening fast ventricular rhythms and who have none of these: ventricular tachycardia that is incessant; slow heart rhythm with symptoms (symptomatic bradycardia); or ventricular tachycardia that recurs often, starts on its own and is reliably ended by antitachycardia pacing (restated from the approval order and the openFDA statement, which reads "INPATIENTS").
  • Not stated in the FDA record.
  • United States (decision by the US Food and Drug Administration).
  • Not stated in the FDA record (it gives no age).
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory decision).
Authority
U.S. Food and Drug Administration
Decision
Approval,
Pathway
PMA
Submission
P110042
Product code
LWS
Device class
Class III
Jurisdictions
United States; note: United States
Product version
Cameron Health Subcutaneous Implantable Defibrillator S-ICD System: SQ-RX Model 1010 pulse generator, Q-TRAK Model 3010 subcutaneous electrode, Q-TECH Model 2020 programmer and Q-GUIDE Model 4010 electrode insertion tool; the original approval, not later supplements or newer models. The order lists procodes LWS and NVY.
Indication
Shock therapy for life-threatening fast ventricular rhythms (ventricular tachyarrhythmias) in patients who have none of these: ventricular tachycardia that is incessant; slow heart rhythm with symptoms (symptomatic bradycardia); or ventricular tachycardia that recurs often, starts on its own and is reliably ended by antitachycardia pacing. Sale limited to prescription use. The applicant named in the approval order and the summary of safety and effectiveness is Cameron Health, Inc.
Basis
The US Food and Drug Administration approved premarket approval application P110042 for a subcutaneous implantable defibrillator system on 28 September 2012. The approval order, dated that day, is addressed to Cameron Health, Inc. of San Clemente, California, and lists the procodes LWS and NVY. The summary of safety and effectiveness names Cameron Health, Inc. as the applicant and describes the system as the pulse generator (SQ-RX Model 1010), the subcutaneous electrode (Q-TRAK Model 3010), the programmer (Q-TECH Model 2020) and the electrode insertion tool (Q-GUIDE Model 4010). The openFDA record, which gives the receipt of the application on 23 December 2011, product code LWS, device class 3 and an expedited review flag of Y, now names Boston Scientific Corporation as the applicant; that field holds the current holder. The approval order and the openFDA approval-order statement (printed in capitals, with the word "INPATIENTS" run together, which is taken here to mean in patients) say the system is meant to give shock therapy for life-threatening fast ventricular rhythms in patients who have none of these: ventricular tachycardia that is incessant; slow heart rhythm with symptoms (symptomatic bradycardia); or ventricular tachycardia that recurs often, starts on its own and is reliably ended by antitachycardia pacing. The order limits sale and distribution to prescription use. The summary of safety and effectiveness describes an electrode designed to be tunneled under the skin from the pocket that holds the pulse generator to a cut near the lower tip of the breastbone, in contrast to transvenous leads.

Limitations. This is the original approval. The openFDA data hold 207 records for P110042, the original and its supplements, including newer models, which are not described here. The approval statement sets who the device is intended for; it does not state that it improves survival or compares it with other defibrillators. The FDA documents are cite-only here, so their wording is restated and not quoted. openFDA data are unvalidated, and its own disclaimer says not to rely on them for medical decisions. The decision's indication text restates the openFDA approval-order statement in the atlas's own words; the statement is printed in capitals and one word is run together, as the claim statement notes.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Record details

Record id
cardio:subcutaneous-icd
Content hash
c31750fe8fb636284ce990f67e0d310f12d051137ef3563a8ea96943f298a624