Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire)

FDA premarket approval P150003/S058 · decided 2020-08-10

Approval details

PMA number

P150003

Supplement

S058

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire)

Generic name

Coronary drug-eluting stent

Applicant

Boston Scientific Corporation

Date received

2019-12-05

Decision date

2020-08-10

Days to decision

249 days

Decision code

APPR

Product code

NIQ

Advisory committee

Cardiovascular

Expedited review

No

Location

Maple Grove, MN

Statement

Approval for the SYNERGY and SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent Systems.The SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those at high risk for bleeding, 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 <= 5.00 mm in diame

510(k) clearances by this applicant