- Device
- Synergy Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P150003
- Supplement
- S044
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2018-12-14
- Decision code
- OK30
- Date received
- 2018-11-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduction in the number of samples used for batch release and annual stability testing for the 4.50 and 5.00 mm stents.