PMA P110019S002

Device: XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S002
Product code: NIQ
Decision date: 2012-01-04
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL TO UPDATE THE LABELING FOR THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM TO REFLECT AN 18 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: S002
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2012-01-04
Decision code: APPR
Date received: 2011-11-14
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO UPDATE THE LABELING FOR THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM TO REFLECT AN 18 MONTH SHELF LIFE.