PMA P150003S081
- Device
- SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Cor
- Applicant
- Boston Scientific Corporation
- PMA number
- P150003
- Supplement
- S081
- Product code
- NIQ
- Decision date
- 2021-12-17
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Introduction of updated glassware for particulate evaluation.
Current openFDA PMA Record#
- Device
- SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Cor
- Applicant
- Boston Scientific Corporation
- PMA number
- P150003
- Supplement
- S081
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-12-17
- Decision code
- OK30
- Date received
- 2021-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of updated glassware for particulate evaluation.