RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS
FDA premarket approval P910020 · decided 1992-06-15
Approval details
- PMA number
- P910020
- Trade name
- RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Boston Scientific
- Date received
- 1991-04-11
- Decision date
- 1992-06-15
- Days to decision
- 431 days
- Decision code
- APWD
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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