PMA P960043S124

Device: Perclose ProGlide® Suture-Mediated Closure System, Prostar® XL Percutaneous Vascular Surgical System
Applicant: Abbott Vascular, Inc.
PMA number: P960043
Supplement: S124
Product code: MGB
Decision date: 2025-02-10
Classification: Cardiovascular
Generic name: Device, hemostasis, vascular
Approval order statement: approval for a manufacturing site located at Centerpiece S. de. R.L. de C.V., Bulevar La Encantada Industrial, Parque Industrial El Florido, Seccion La Encantada 11530, Tijuana, Baja California, 22250, Mexico for sterilization.

Current openFDA PMA Record#

Device: Perclose ProGlide® Suture-Mediated Closure System, Prostar® XL Percutaneous Vascular Surgical System
Applicant: Abbott Vascular, Inc.
PMA number: P960043
Supplement: S124
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2025-02-10
Decision code: APPR
Date received: 2024-09-06
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a manufacturing site located at Centerpiece S. de. R.L. de C.V., Bulevar La Encantada Industrial, Parque Industrial El Florido, Seccion La Encantada 11530, Tijuana, Baja California, 22250, Mexico for sterilization.