PMA P110019S078

Device: XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S078
Product code: NIQ
Decision date: 2015-10-22
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: CHANGE TO THE ACCEPTANCE SAMPLING SYSTEM FOR DISLODGEMENT TESTING FOR THE XIENCE PRIME AND XIENCE PRIME II EVEROLIMUS ELUTING CORONARY STENT SYSTEM.

Current openFDA PMA Record#

Device: XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S078
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2015-10-22
Decision code: OK30
Date received: 2015-09-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE ACCEPTANCE SAMPLING SYSTEM FOR DISLODGEMENT TESTING FOR THE XIENCE PRIME AND XIENCE PRIME II EVEROLIMUS ELUTING CORONARY STENT SYSTEM.