PMA P960043S103

Device: Perclose ProGlide Suture-Mediated Closure System
Applicant: Abbott Vascular, Inc.
PMA number: P960043
Supplement: S103
Product code: MGB
Decision date: 2018-12-27
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: Implement an alternate supplier for manufacturing four extruded tubing components used in the Perclose ProGlide Suture-Mediated Closure System.

Current openFDA PMA Record#

Device: Perclose ProGlide Suture-Mediated Closure System
Applicant: Abbott Vascular, Inc.
PMA number: P960043
Supplement: S103
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2018-12-27
Decision code: OK30
Date received: 2018-11-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement an alternate supplier for manufacturing four extruded tubing components used in the Perclose ProGlide Suture-Mediated Closure System.