PMA P110019S060

Device: XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM,
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S060
Product code: NIQ
Decision date: 2014-05-29
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL FOR A CHANGE IN THE RESIN COMPOSITION OF POLYPROPYLENE SUPPLY ITEMS USED IN XIENCE PRIMER AND DRUG FORMULATION MANUFACTURING.

Current openFDA PMA Record#

Device: XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM,
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S060
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2014-05-29
Decision code: APPR
Date received: 2013-12-23
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE IN THE RESIN COMPOSITION OF POLYPROPYLENE SUPPLY ITEMS USED IN XIENCE PRIMER AND DRUG FORMULATION MANUFACTURING.