# Subcutaneous ICD (S-ICD) system

Product · id `cardio:subcutaneous-icd` · Cardiovascular Atlas · release `73130c34862e2d06` (public)

> General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here.

The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations.

Also called: S-ICD

Browse, condition area: Heart rhythm problems  

## In plain language

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.

## 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.

## Claims, with the population each applies to

## 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).

### 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.

- Category: Regulatory
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: 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).
- 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
- Sources:
  1. Supports: FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1>
     Locator: results\[0\].pma\_number. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c.
     How it applies: openFDA record field.
  2. Supports: FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1>
     Locator: results\[0\].applicant. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c.
     How it applies: openFDA record field.
  3. Supports: FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1>
     Locator: results\[0\].trade\_name. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c.
     How it applies: openFDA record field.
  4. Supports: FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1>
     Locator: results\[0\].generic\_name. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c.
     How it applies: openFDA record field.
  5. Supports: FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1>
     Locator: results\[0\].product\_code. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c.
     How it applies: openFDA record field.
  6. Supports: FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1>
     Locator: results\[0\].decision\_date. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c.
     How it applies: openFDA record field.
  7. Supports: FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1>
     Locator: results\[0\].date\_received. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c.
     How it applies: openFDA record field.
  8. Supports: FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1>
     Locator: results\[0\].decision\_code. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c.
     How it applies: openFDA record field.
  9. Supports: FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1>
     Locator: results\[0\].openfda.device\_class. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c.
     How it applies: openFDA record field.
  10. Supports: FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1>
     Locator: results\[0\].expedited\_review\_flag. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c.
     How it applies: openFDA record field.
  11. Supports: FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement (fragment 1 of 4). Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c.
     How it applies: Approval-order statement, as openFDA prints it (fragment).
  12. Supports: FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement (fragment 2 of 4). Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c.
     How it applies: Approval-order statement, as openFDA prints it (fragment).
  13. Supports: FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement (fragment 3 of 4). Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c.
     How it applies: Approval-order statement, as openFDA prints it (fragment).
  14. Supports: FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement (fragment 4 of 4). Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c.
     How it applies: Approval-order statement, as openFDA prints it (fragment).
  15. Background: FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1>
     Locator: meta.disclaimer. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c.
     How it applies: openFDA's own disclaimer about relying on its data.
  16. Supports: FDA approval order for PMA P110042 (subcutaneous implantable defibrillator system, 28 September 2012) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext. The text layer is imperfect in places, so only short lines are quoted.) <https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110042A.pdf>
     Locator: Page 1, addressee. Retrieved 2026-10-15T14:44:29Z. Source state: Current. Snapshot hash: aa5df2300ea5f2a6ccf140de6baa28eb0d38b277d6b90ddbcc3eea88bf6cd862.
     How it applies: Statement in the cited record.
  17. Supports: FDA approval order for PMA P110042 (subcutaneous implantable defibrillator system, 28 September 2012) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext. The text layer is imperfect in places, so only short lines are quoted.) <https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110042A.pdf>
     Locator: Page 1, date line. Retrieved 2026-10-15T14:44:29Z. Source state: Current. Snapshot hash: aa5df2300ea5f2a6ccf140de6baa28eb0d38b277d6b90ddbcc3eea88bf6cd862.
     How it applies: Statement in the cited record.
  18. Supports: FDA approval order for PMA P110042 (subcutaneous implantable defibrillator system, 28 September 2012) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext. The text layer is imperfect in places, so only short lines are quoted.) <https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110042A.pdf>
     Locator: Page 1, Re: line. Retrieved 2026-10-15T14:44:29Z. Source state: Current. Snapshot hash: aa5df2300ea5f2a6ccf140de6baa28eb0d38b277d6b90ddbcc3eea88bf6cd862.
     How it applies: Statement in the cited record.
  19. Supports: FDA approval order for PMA P110042 (subcutaneous implantable defibrillator system, 28 September 2012) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext. The text layer is imperfect in places, so only short lines are quoted.) <https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110042A.pdf>
     Locator: Page 1, sale and distribution. Retrieved 2026-10-15T14:44:29Z. Source state: Current. Snapshot hash: aa5df2300ea5f2a6ccf140de6baa28eb0d38b277d6b90ddbcc3eea88bf6cd862.
     How it applies: Statement in the cited record.
  20. Supports: FDA summary of safety and effectiveness data for PMA P110042 (S-ICD system) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext.) <https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110042B.pdf>
     Locator: Section I, general information. Retrieved 2026-10-15T14:44:29Z. Source state: Current. Snapshot hash: 8a052560d1cc4bc0195cef255be69a40c02be986894204fba85a5be0eb2402b9.
     How it applies: Statement in the cited record.
  21. Supports: FDA summary of safety and effectiveness data for PMA P110042 (S-ICD system) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext.) <https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110042B.pdf>
     Locator: Section I, device trade name. Retrieved 2026-10-15T14:44:29Z. Source state: Current. Snapshot hash: 8a052560d1cc4bc0195cef255be69a40c02be986894204fba85a5be0eb2402b9.
     How it applies: Statement in the cited record.
  22. Supports: FDA summary of safety and effectiveness data for PMA P110042 (S-ICD system) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext.) <https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110042B.pdf>
     Locator: Section I, general information (quote 2). Retrieved 2026-10-15T14:44:29Z. Source state: Current. Snapshot hash: 8a052560d1cc4bc0195cef255be69a40c02be986894204fba85a5be0eb2402b9.
     How it applies: Statement in the cited record.
  23. Supports: FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1>
     Locator: meta.results.total. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c.
     How it applies: Statement in the cited record.

## Guidance, authorization and access

### Regulatory decision `cardio:regdec-fda-p110042`

- Product: Subcutaneous ICD (S-ICD) system (`cardio:subcutaneous-icd`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Approval, 2012-09-28
- 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.
- Pathway: PMA
- Submission: P110042
- Product code: LWS
- Device class: III
- 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.
- Jurisdictions: United States; note: United States
- Applies to: 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).
- Basis: claim `cardio:claim-fda-p110042-approval`

## Connected pages

- A defibrillator that is implanted: Implantable cardioverter-defibrillator (ICD) (`cardio:implantable-cardioverter-defibrillator`)
- Manufacturing establishment in the current openFDA listing, and the applicant openFDA now lists for P110042: Boston Scientific (`cardio:boston-scientific`)
- Filed under this front: Devices and monitoring (`cardio:front-devices-and-monitoring`)

## Provenance

Content hash: c31750fe8fb636284ce990f67e0d310f12d051137ef3563a8ea96943f298a624
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-15