SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM(OVER-THE-WIRE& MONORAIL)

FDA premarket approval P150003/S003 · decided 2016-07-29

Approval details

PMA number

P150003

Supplement

S003

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM(OVER-THE-WIRE& MONORAIL)

Generic name

Coronary drug-eluting stent

Applicant

Boston Scientific Corporation

Date received

2015-12-07

Decision date

2016-07-29

Days to decision

235 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 (Monorail™ and Over-The-Wire). This device is indicated for improving luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries >=2.25 mm to <=4.00 mm in diameter in lesions <=34 mm in length.

510(k) clearances by this applicant