RELAY-DASH PACING SYSTEM
FDA premarket approval P910020/S005 · decided 1994-06-09
Approval details
- PMA number
- P910020
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RELAY-DASH PACING SYSTEM
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Boston Scientific
- Date received
- 1993-04-19
- Decision date
- 1994-06-09
- Days to decision
- 416 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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