- Device
- SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System; SYNERGY XD Everolimus-Eluting Platinum Chromium Coro
- Applicant
- Boston Scientific Corporation
- PMA number
- P150003
- Supplement
- S109
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2025-04-18
- Decision code
- OK30
- Date received
- 2025-03-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes in sample sizes and other acceptance sampling criteria in the OQ/PQ protocols for initial and repeat lines of Synergy XD/Megatron Inner Packaging process and for repeat lines of Synergy Dryer, Synergy/Synergy Shield Inner Pack and Secondary Pack processes