VIGOR(TM) DR PACEMAKER SYSTEM
FDA premarket approval P940031 · decided 1995-06-21
Approval details
- PMA number
- P940031
- Trade name
- VIGOR(TM) DR PACEMAKER SYSTEM
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Boston Scientific
- Date received
- 1994-09-30
- Decision date
- 1995-06-21
- Days to decision
- 264 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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