RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS
FDA premarket approval P910020/S001 · decided 1992-12-29
Approval details
- PMA number
- P910020
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Boston Scientific
- Date received
- 1992-05-11
- Decision date
- 1992-12-29
- Days to decision
- 232 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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