PMA P110019S070

Device: XIENCE ALPINE RX & OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S070
Product code: NIQ
Decision date: 2014-09-03
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL TO CHANGE THE DISTAL BALLOON SHAFT, DISTAL OUTER MEMBER AND PROXIMAL HYPOTUBE COMPONENTS FOR THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM. YOU INDICATED THAT UPON IMPLEMENTATION OF THESE CHANGES, THE NEW NAME FOR THE CORONARY STENT SYSTEM WILL BE THE XIENCE ALPINE¿ EVEROLIMUS ELUTING CORONARY STENT SYSTEM.

Current openFDA PMA Record#

Device: XIENCE ALPINE RX & OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S070
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2014-09-03
Decision code: APPR
Date received: 2014-06-04
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO CHANGE THE DISTAL BALLOON SHAFT, DISTAL OUTER MEMBER AND PROXIMAL HYPOTUBE COMPONENTS FOR THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM. YOU INDICATED THAT UPON IMPLEMENTATION OF THESE CHANGES, THE NEW NAME FOR THE CORONARY STENT SYSTEM WILL BE THE XIENCE ALPINE¿ EVEROLIMUS ELUTING CORONARY STENT SYSTEM.