PMA P070015S146

Device: XIENCE V and XIENCE Nano EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Applicant: Abbott Vascular, Inc.
PMA number: P070015
Supplement: S146
Product code: NIQ
Decision date: 2020-03-19
Generic name: Coronary drug-eluting stent
Approval order statement: Approval for changing the ethylene oxide (EO) sterilization release process for the affected products from the traditional method of biological indicator testing to a parametric release process.

Current openFDA PMA Record#

Device: XIENCE V and XIENCE Nano EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Applicant: Abbott Vascular, Inc.
PMA number: P070015
Supplement: S146
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2020-03-19
Decision code: APPR
Date received: 2019-09-26
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for changing the ethylene oxide (EO) sterilization release process for the affected products from the traditional method of biological indicator testing to a parametric release process.