SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System, SYNERGY SHIELD Everolimus Eluting Platinum Chromi

FDA premarket approval P150003/S105 · decided 2025-01-27

Approval details

PMA number

P150003

Supplement

S105

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System, SYNERGY SHIELD Everolimus Eluting Platinum Chromi

Generic name

Coronary drug-eluting stent

Applicant

Boston Scientific Corporation

Date received

2024-07-31

Decision date

2025-01-27

Days to decision

180 days

Decision code

APPR

Product code

NIQ

Advisory committee

Cardiovascular

Expedited review

No

Location

Maple Grove, MN

Statement

improving luminal diameter in patients, including those at high risk for bleeding, with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, ST-elevation MI (STEMI), non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries ?2.25 mm to ?5.00 mm in diameter in lesions ?34 mm in length.

510(k) clearances by this applicant