PMA P960043S133

Device: Perclose ProGlide™ Suture-Mediated Closure System; Perclose™ ProStyle™ Suture-Mediated Closure and Repair System
Applicant: Abbott Vascular, Inc.
PMA number: P960043
Supplement: S133
Product code: MGB
Decision date: 2026-04-17
Classification: Cardiovascular
Generic name: Device, hemostasis, vascular
Approval order statement: implementation of the sustainable ethylene oxide (SEO) cycle in Chamber 1 and Chamber 2 at Sterigenics UK

Current openFDA PMA Record#

Device: Perclose ProGlide™ Suture-Mediated Closure System; Perclose™ ProStyle™ Suture-Mediated Closure and Repair System
Applicant: Abbott Vascular, Inc.
PMA number: P960043
Supplement: S133
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2026-04-17
Decision code: OK30
Date received: 2026-03-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of the sustainable ethylene oxide (SEO) cycle in Chamber 1 and Chamber 2 at Sterigenics UK