EMBLEM SUBCUTANEOUS IMPLANTABLE CARDIAC DEFIBRILLATOR (S ICD )
FDA premarket approval P110042/S050 · decided 2015-10-07
Approval details
- PMA number
- P110042
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EMBLEM SUBCUTANEOUS IMPLANTABLE CARDIAC DEFIBRILLATOR (S ICD )
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2015-09-17
- Decision date
- 2015-10-07
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- MANUFACTURE THE SPRING CONNECTOR BLOCK HOUSING COMPONENTS FOR THE REFERENCED PULSE GENERATORS AT BOSTON SCIENTIFIC CORPORATION FACILITY, ST. PAUL, MN
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