PMA P110019S105

Device: XIENCE PRIME SV/LL Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIEN
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S105
Product code: NIQ
Decision date: 2019-07-12
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: Changes to the gowning regime and reclassification of the manufacturing environment.

Current openFDA PMA Record#

Device: XIENCE PRIME SV/LL Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIEN
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S105
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2019-07-12
Decision code: OK30
Date received: 2019-06-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to the gowning regime and reclassification of the manufacturing environment.