PMA P110019S055

Device: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S055
Product code: NIQ
Decision date: 2014-01-14
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL FOR A LABELING CHANGE FOR THE XIENCE XPEDITION , XIENCE XPEDITION SV, AND THE XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM FOR THE OTW PLATFORM. THIS LABELING CHANGE REQUESTED A SHELF LIFE EXTENSION FROM 12 TO 24 MONTHS.

Current openFDA PMA Record#

Device: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S055
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2014-01-14
Decision code: APPR
Date received: 2013-10-18
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A LABELING CHANGE FOR THE XIENCE XPEDITION , XIENCE XPEDITION SV, AND THE XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM FOR THE OTW PLATFORM. THIS LABELING CHANGE REQUESTED A SHELF LIFE EXTENSION FROM 12 TO 24 MONTHS.