DYNAGEN MINI, INOGEN MINI, ORIGEN MINI and PERCIVA MINI
FDA premarket approval P960040/S427 · decided 2018-07-11
Approval details
- PMA number
- P960040
- Supplement
- S427
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DYNAGEN MINI, INOGEN MINI, ORIGEN MINI and PERCIVA MINI
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2018-06-27
- Decision date
- 2018-07-11
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Vertical integration for the Mini high voltage capacitor can manufacturing process.
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