Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System

FDA premarket approval P110010 · Coronary drug-eluting stent

PMA numberP110010

Approval

Applicant
Boston Scientific Corp
Received
March 28, 2011
Decision date
November 22, 2011 (APPR)
Supplements
207, latest January 14, 2025
Product code
NIQ – Coronary Drug-Eluting Stent

Official FDA PMA record

Approval order statement

APPROVAL FOR THE PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=28 MM INLENGTH.