PMA P110019S039

Device: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S039
Product code: NIQ
Decision date: 2013-06-28
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT VASCULAR COSTA RICA (A VCR) IN EL COYO ALAJUELA, COSTA RICA.

Current openFDA PMA Record#

Device: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S039
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2013-06-28
Decision code: APPR
Date received: 2013-01-17
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT VASCULAR COSTA RICA (A VCR) IN EL COYO ALAJUELA, COSTA RICA.