RELAY/DASH/STRIDE/DART PACING SYSTEMS
FDA premarket approval P910020/S011 · decided 1996-03-22
Approval details
- PMA number
- P910020
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RELAY/DASH/STRIDE/DART PACING SYSTEMS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Boston Scientific
- Date received
- 1995-09-05
- Decision date
- 1996-03-22
- Days to decision
- 199 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE CHANGE IN STERILANT FROM AMIXTURE OF 12% ETHYLENE OXIDE AND 88% FREON TO A MIXTURE OF 8.5% ETHYLENE OXIDE AND 91.5% CARBON DIOXIDE
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