SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
FDA premarket approval P110042/S009 · decided 2013-08-28
Approval details
- PMA number
- P110042
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2013-06-10
- Decision date
- 2013-08-28
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODEL 3200 Q-TECH PROGRAMMER TO BE USED WITH SQ-RX® PULSE GENERATOR (MODEL 1010) OF THE SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD®) SYSTEM ONLY.
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