PMA P110019S066

Device

XIENCE PRIME EVERLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE X PEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Applicant

Abbott Vascular

PMA number

P110019

Supplement

S066

Product code

NIQ

Decision date

2014-10-03

Classification

Coronary Drug-eluting Stent

Generic name

Coronary drug-eluting stent

Approval order statement

APPROVAL FOR THE EXPANSION OF THE INDICATIONS FOR USE OF THE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION, XIENCE XPEDITION SV AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM, AND XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM TO INCLUDE DE NOVO TOTAL CORONARY OCCLUSIONS.. THESE DEVICES ARE INDICATED FOR THE FOLLOWING:XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMTHE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <=28MM) WITH REFERENCE VESSEL DIAMETERS OF 2.25MM TO 4.25MM. ADDITIONALLY, THE XIENCE V STENT SYSTEM IS INDICATED FOR TREATING DE NOVO CHRONIC TOTAL CORONARY OCCLUSIONS. XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THE XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY ARTERY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 32MM) WITH REFERENCE VESSEL DIAMETERS OF >=2.25MM TO >=4.25MM. FOR ADDITIONAL INFO PLEASE REFER TO APPROVAL ORDER.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110019S066B.pdf" target="_new">Summary of Safety and Effectiveness</a>