EDGEBAND PACER RELAY MODEL 294-03E
FDA premarket approval P910020/S018 · decided 1997-11-18
Approval details
- PMA number
- P910020
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EDGEBAND PACER RELAY MODEL 294-03E
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Boston Scientific
- Date received
- 1997-06-09
- Decision date
- 1997-11-18
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the Relay Model 294-03E edgeband pulse generator.
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