VIGOR SSI PACEMAKER SYSTEM
FDA premarket approval P840068/S024 · decided 1995-06-05
Approval details
- PMA number
- P840068
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VIGOR SSI PACEMAKER SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1995-03-16
- Decision date
- 1995-06-05
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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