PMA P110019S042

Device: XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S042
Product code: NIQ
Decision date: 2013-03-22
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: CHANGE THE PARTICULATE COUNT SAMPLING PLAN FOR THE XIENCE PRIME, XIENCE PRIME LL, AND XIENCE XPEDITION EECSS.

Current openFDA PMA Record#

Device: XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S042
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2013-03-22
Decision code: OK30
Date received: 2013-02-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE THE PARTICULATE COUNT SAMPLING PLAN FOR THE XIENCE PRIME, XIENCE PRIME LL, AND XIENCE XPEDITION EECSS.