PMA P110019S041

Device: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY SYSTEM, XIENC
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S041
Product code: NIQ
Decision date: 2013-04-25
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL FOR A STERILIZATION SITE LOCATED AT ABBOTT NUTRITION IRELAND, IN SLIGO, IRELAND.

Current openFDA PMA Record#

Device: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY SYSTEM, XIENC
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S041
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2013-04-25
Decision code: APPR
Date received: 2013-01-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A STERILIZATION SITE LOCATED AT ABBOTT NUTRITION IRELAND, IN SLIGO, IRELAND.