PMA P110019S043

Device: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S043
Product code: NIQ
Decision date: 2013-07-15
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL TO UPDATE THE LABELING FOR THE XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT RAPID EXCHANGE (RX) SYSTEM TO REFLECT A 24-MONTH SHELF LIFE.

Current openFDA PMA Record#

Device: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S043
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2013-07-15
Decision code: APPR
Date received: 2013-04-17
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO UPDATE THE LABELING FOR THE XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT RAPID EXCHANGE (RX) SYSTEM TO REFLECT A 24-MONTH SHELF LIFE.