SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA premarket approval P150003 · decided 2015-10-02
Approval details
- PMA number
- P150003
- Trade name
- SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corporation
- Date received
- 2015-01-15
- Decision date
- 2015-10-02
- Days to decision
- 260 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR THE SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE, STABLEANGINA, UNSTABLE ANGINA, NON-ST ELEVATION MI OR DOCUMENTED SILENT ISCHEMIA DUE TO ATHEROSCLEROTIC LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.0 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH.
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