PMA P150003S064
- Device
- SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire)
- Applicant
- Boston Scientific Corporation
- PMA number
- P150003
- Supplement
- S064
- Product code
- NIQ
- Decision date
- 2020-08-20
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Removal of an initial soaking step as pat of the electropolishing process.
Current openFDA PMA Record#
- Device
- SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire)
- Applicant
- Boston Scientific Corporation
- PMA number
- P150003
- Supplement
- S064
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-08-20
- Decision code
- OK30
- Date received
- 2020-08-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of an initial soaking step as pat of the electropolishing process.