- Device
- SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGY XD Everolimus-Eluting Platinum Chromium Coron
- Applicant
- Boston Scientific Corporation
- PMA number
- P150003
- Supplement
- S113
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2026-08-21
- Decision code
- OK30
- Date received
- 2026-07-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of parametric release and an alternate biological indicator at the sterilization sites