{ "release_id": "73130c34862e2d06", "id": "cardio:subcutaneous-icd", "owner": "cardio", "kind": "product", "slug": "subcutaneous-icd", "name": "Subcutaneous ICD (S-ICD) system", "aliases": [ "S-ICD" ], "atlases": [ "cardio" ], "summary_plain": "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.", "summary_technical": "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.", "editorial_state": "draft", "last_substantive_edit": "2026-10-15", "last_evidence_check": "2026-10-15", "next_review_due": null, "identifiers": [], "navigation": { "cardio": { "condition-area": [ "arrhythmias" ] } }, "payload": { "subtype": "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_snapshots": [ "cardio:openfda-pma-p110042-2026-10-15", "cardio:fda-p110042-ssed-2026-10-15" ] }, "content_digest": "c31750fe8fb636284ce990f67e0d310f12d051137ef3563a8ea96943f298a624", "review": { "content_digest": "c31750fe8fb636284ce990f67e0d310f12d051137ef3563a8ea96943f298a624", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "73130c34862e2d06", "id": "cardio:claim-fda-p110042-approval", "owner": "cardio", "subject_entity_id": "cardio:subcutaneous-icd", "category": "regulatory", "statement": "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.", "context": { "id": "cardio:ctx-fda-p110042-us-approval", "label": "United States premarket approval P110042 for the subcutaneous implantable defibrillator system (S-ICD)", "recipient": "unknown", "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_note": "Not stated in the FDA record (it gives no age).", "life_stage_terms": null, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (regulatory decision).", "eligibility": { "inclusion": [ "Life-threatening fast ventricular rhythms needing shock therapy" ], "exclusion": [ "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" ] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "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.", "editorial_state": "draft", "checked_at": "2026-10-15", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "results[0].pma_number", "applicability_note": "openFDA record field.", "snapshot": { "id": "cardio:openfda-pma-p110042-2026-10-15", "retrieved_at": "2026-10-15T13:49:53Z", "content_hash": "26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p110042", "source_type": "regulator", "title": "FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P110042", "normalized_value": "P110042", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "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.", "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.", "public_text": "quote", "replaced_by": null, "retirement_note": null } }, { "evidence_role": "supports", "locator": "results[0].applicant", "applicability_note": "openFDA record field.", "snapshot": { "id": "cardio:openfda-pma-p110042-2026-10-15", "retrieved_at": "2026-10-15T13:49:53Z", "content_hash": "26e1b9973a155a0bc1aef8e0ab3942fcfce71f9e6a5b1360a516975ce8b00e8c", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-pma-p110042", "source_type": "regulator", "title": "FDA premarket approval P110042: subcutaneous implantable defibrillator (S-ICD) system (openFDA record of the original approval)", "canonical_url": "https://api.fda.gov/device/pma.json?search=pma_number:P110042&sort=decision_date:asc&limit=1", "identifiers": [ { "scheme": "fda-pma", "value": "P110042", "normalized_value": "P110042", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "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. 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