PMA P110019S095

Device: XIENCE PRIME Everolimus Eluting Coronary Stent System / SV / LL ; XIENCE Xpedition Everolimus Eluting Coronary Stent Sys
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S095
Product code: NIQ
Decision date: 2018-01-25
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: Approval to change the ethylene oxide (EO) sterilization release process for the affected products from using the traditional method of biological indicator testing to a parametric release process.

Current openFDA PMA Record#

Device: XIENCE PRIME Everolimus Eluting Coronary Stent System / SV / LL ; XIENCE Xpedition Everolimus Eluting Coronary Stent Sys
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S095
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2018-01-25
Decision code: APPR
Date received: 2017-09-28
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to change the ethylene oxide (EO) sterilization release process for the affected products from using the traditional method of biological indicator testing to a parametric release process.