PMA P040038S032

Device: XACT Carotid Stent System
Applicant: Abbott Vascular, Inc.
PMA number: P040038
Supplement: S032
Product code: NIM
Decision date: 2018-01-25
Classification: Stent, Carotid
Generic name: Stent, carotid
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: XACT Carotid Stent System
Applicant: Abbott Vascular, Inc.
PMA number: P040038
Supplement: S032
Product code: NIM
Generic name: Stent, carotid
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.