PMA P110019S011

Device: XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S011
Product code: NIQ
Decision date: 2012-09-10
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL FOR TRANSFERRING THE TESTING OF TOTAL ORGANIC CARBON (TOC) FROM A CONTRACT LABORATORY TO ABBOTT VASCULAR IN TEMECULA, CA.

Current openFDA PMA Record#

Device: XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S011
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2012-09-10
Decision code: APPR
Date received: 2012-02-01
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR TRANSFERRING THE TESTING OF TOTAL ORGANIC CARBON (TOC) FROM A CONTRACT LABORATORY TO ABBOTT VASCULAR IN TEMECULA, CA.