- Device
- SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System and SYNERGY XD Everolimus-Eluting Platinum Chromium C
- Applicant
- Boston Scientific Corporation
- PMA number
- P150003
- Supplement
- S065
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-10-13
- Decision code
- OK30
- Date received
- 2020-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional of two UV Bonders to the catheter manufacturing lines.