PMA P910020S011
- Device
- Relay/dash/stride/dart Pacing Systems
- Applicant
- BOSTON SCIENTIFIC
- PMA number
- P910020
- Supplement
- S011
- Decision date
- 1996-03-22
Current openFDA PMA Record
- Device
- RELAY/DASH/STRIDE/DART PACING SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P910020
- Supplement
- S011
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 1996-03-22
- Decision code
- APPR
- Date received
- 1995-09-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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