PMA P110019S061

Device: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, OTW PLATFORM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S061
Product code: NIQ
Decision date: 2014-03-26
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 24 TO 36 MONTHS.

Current openFDA PMA Record#

Device: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, OTW PLATFORM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S061
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2014-03-26
Decision code: APPR
Date received: 2014-01-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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 24 TO 36 MONTHS.