SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
FDA premarket approval P110042 · decided 2012-09-28
Approval details
- PMA number
- P110042
- Trade name
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2011-12-23
- Decision date
- 2012-09-28
- Days to decision
- 280 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM. THIS DEVICE IS INDICATED TO PROVIDE DEFIBRILLATION THERAPY FOR THE TREATMENT OF LIFE-THREATENING VENTRICULAR TACHYARRHYTHMIAS INPATIENTS WHO DO NOT HAVE SYMPTOMATIC BRADYCARDIA, INCESSANT VENTRICULAR TACHYCARDIA, OR SPONTANEOUS, FREQUENTLY RECURRING VENTRICULAR TACHYCARDIA THAT IS RELIABLY TERMINATED WITH ANTITACHYCARDIA PACING.
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