SYNERGY™ XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail™)

FDA premarket approval P150003/S055 · decided 2020-05-28

Approval details

PMA number

P150003

Supplement

S055

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

SYNERGY™ XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail™)

Generic name

Coronary drug-eluting stent

Applicant

Boston Scientific Corporation

Date received

2019-10-28

Decision date

2020-05-28

Days to decision

213 days

Decision code

APPR

Product code

NIQ

Advisory committee

Cardiovascular

Expedited review

No

Location

Maple Grove, MN

Statement

Approval for 48 mm device lengths for the 2.50 to 4.00 mm devices along with modifications to the delivery catheter design and changes to the packaging design. The device, as modified, will be marketed under the trade name SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System and 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 isch

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