PMA P110019S010

Device: XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S010
Product code: NIQ
Decision date: 2012-02-21
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: MODIFICATION OF A MARKER ALIGNMENT TEMPLATE; AND A CHANGE TO THE IN-PROCESS ACCEPTANCE CRITERIA FOR ONE BALLOON LENGTH SIZE.

Current openFDA PMA Record#

Device: XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S010
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2012-02-21
Decision code: OK30
Date received: 2012-01-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MODIFICATION OF A MARKER ALIGNMENT TEMPLATE; AND A CHANGE TO THE IN-PROCESS ACCEPTANCE CRITERIA FOR ONE BALLOON LENGTH SIZE.