CAMERON HEALTH SUBCUTANCEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM
FDA premarket approval P110042/S014 · decided 2013-09-27
Approval details
- PMA number
- P110042
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAMERON HEALTH SUBCUTANCEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2013-08-05
- Decision date
- 2013-09-27
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR TWO ALTERNATE SILICON CAPACITORS USED ON THE LOW POWER HYBRID ASSEMBLY FOR THE S-ICD SYSTEM.
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