Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System

FDA premarket approval P150003 · Coronary drug-eluting stent

PMA numberP150003

Approval

Applicant
Boston Scientific Corporation
Received
January 15, 2015
Decision date
October 2, 2015 (APPR)
Supplements
109, latest August 21, 2026
Product code
NIQ – Coronary Drug-Eluting Stent

Official FDA PMA record

Approval order 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.