Xience Skypoint Everolimus Eluting Coronary Stent System

FDA premarket approval P110019 · Coronary drug-eluting stent

PMA numberP110019

Approval

Applicant
Abbott Vascular
Received
April 20, 2011
Decision date
November 1, 2011 (APPR)
Supplements
133, latest August 28, 2026
Product code
NIQ – Coronary Drug-Eluting Stent

Official FDA PMA record

Approval order statement

APPROVAL FOR THE XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 32 MM) WITH REFERENCE VESSEL DIAMETERS OF >= 2.25 MM TO <= 4.25 MM.