PMA P110019S111

Device: XIENCE PRIME SV Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S111
Product code: NIQ
Decision date: 2020-03-12
Generic name: Coronary drug-eluting stent
Approval order statement: Extend the retest period from 96 months to 108 months of the repackaged drug API (variants 1, 2, and 3) for container closure Configuration I.

Current openFDA PMA Record#

Device: XIENCE PRIME SV Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S111
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2020-03-12
Decision code: OK30
Date received: 2020-02-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Extend the retest period from 96 months to 108 months of the repackaged drug API (variants 1, 2, and 3) for container closure Configuration I.