PMA P070015S147

Device: XIENCE V Everolimus Eluting Coronary Stent System, XIENCE nano Everolimus Eluting Coronary Stent System
Applicant: Abbott Vascular, Inc.
PMA number: P070015
Supplement: S147
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 V Everolimus Eluting Coronary Stent System, XIENCE nano Everolimus Eluting Coronary Stent System
Applicant: Abbott Vascular, Inc.
PMA number: P070015
Supplement: S147
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.