RELAY/DASH/STRIDE & DART PACING SYSTEM
FDA premarket approval P910020/S003 · decided 1994-05-06
Approval details
- PMA number
- P910020
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RELAY/DASH/STRIDE & DART PACING SYSTEM
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Boston Scientific
- Date received
- 1992-07-30
- Decision date
- 1994-05-06
- Days to decision
- 645 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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