PMA P150003S060
- Device
- Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P150003
- Supplement
- S060
- Product code
- NIQ
- Decision date
- 2020-04-09
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Changes to the mechanism used to crimp the stent to its final profile.
Current openFDA PMA Record#
- Device
- Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P150003
- Supplement
- S060
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-04-09
- Decision code
- OK30
- Date received
- 2020-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the mechanism used to crimp the stent to its final profile.