PMA P960043S132

Device: Perclose ProGlide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System
Applicant: Abbott Vascular, Inc.
PMA number: P960043
Supplement: S132
Product code: MGB
Decision date: 2026-04-01
Classification: Cardiovascular
Generic name: Device, hemostasis, vascular
Approval order statement: relocation of the link and suture subassemblies to a different area within the existing manufacturing facility

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: S132
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2026-04-01
Decision code: OK30
Date received: 2026-03-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: relocation of the link and suture subassemblies to a different area within the existing manufacturing facility