PMA P150003S006
- Device
- SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P150003
- Supplement
- S006
- Product code
- NIQ
- Decision date
- 2016-08-17
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Approval for changes to the gradient outers and manifold component of the delivery system.
Current openFDA PMA Record#
- Device
- SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P150003
- Supplement
- S006
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2016-08-17
- Decision code
- APPR
- Date received
- 2016-02-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the gradient outers and manifold component of the delivery system.