PMA P110019S008

Device: XIENCE PRIME & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S008
Product code: NIQ
Decision date: 2012-01-20
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: ADDITION OF AN ALTERNATE MANUFACTURING SITE FOR DRUG SUBLOTTING AND THE IMPLEMENTATION OF A NEW PIECE OF EQUIPMENT FOR POUCH SEALING.

Current openFDA PMA Record#

Device: XIENCE PRIME & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S008
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2012-01-20
Decision code: OK30
Date received: 2011-12-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF AN ALTERNATE MANUFACTURING SITE FOR DRUG SUBLOTTING AND THE IMPLEMENTATION OF A NEW PIECE OF EQUIPMENT FOR POUCH SEALING.