UNITY - C MODEL 292-06 PULSE GENERATOR & ACCS.
FDA premarket approval P910020/S004 · decided 1995-01-23
Approval details
- PMA number
- P910020
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UNITY - C MODEL 292-06 PULSE GENERATOR & ACCS.
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Boston Scientific
- Date received
- 1992-12-07
- Decision date
- 1995-01-23
- Days to decision
- 777 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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