PMA P110019S067

Device: XIENCE PRIME/XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S067
Product code: NIQ
Decision date: 2014-05-13
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: ADDITION OF RECEIVING INSPECTION AND TESTING ACTIVITIES OF RAW MATERIALS AND SUPPLY ITEMS AT THE CLONMEL, IRELAND FACILITY AND CONTRACT LABORATORIES.

Current openFDA PMA Record#

Device: XIENCE PRIME/XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S067
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2014-05-13
Decision code: OK30
Date received: 2014-04-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF RECEIVING INSPECTION AND TESTING ACTIVITIES OF RAW MATERIALS AND SUPPLY ITEMS AT THE CLONMEL, IRELAND FACILITY AND CONTRACT LABORATORIES.