PMA P110019S023

Device: XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S023
Product code: NIQ
Decision date: 2012-08-06
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL FOR UPDATING LABELING FOR THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM TO REFLECT A 24 MONTH SHELF LIFE.

Current openFDA PMA Record#

Device: XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S023
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2012-08-06
Decision code: APPR
Date received: 2012-06-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR UPDATING LABELING FOR THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM TO REFLECT A 24 MONTH SHELF LIFE.