SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR
FDA premarket approval P110042/S035 · decided 2014-05-30
Approval details
- PMA number
- P110042
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2014-05-08
- Decision date
- 2014-05-30
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGES RELATED TO MANUFACTURING PROCESS OF THE BATTERY INCLUDING QUALIFYING A NEW WELD MACHINE, MODIFYING THE INSULATING TAPE USED IN SHIPPING, AND NEW FIXTURES.
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