PMA P960043S104

Device: Prostar XL Percutaneous Vascular Surgical System
Applicant: Abbott Vascular, Inc.
PMA number: P960043
Supplement: S104
Product code: MGB
Decision date: 2019-05-23
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: Manufacturing move within an approved facility for the Prostar XL Percutaneous Vascular Surgical System and the StarClose SE Vascular Closure System.

Current openFDA PMA Record#

Device: Prostar XL Percutaneous Vascular Surgical System
Applicant: Abbott Vascular, Inc.
PMA number: P960043
Supplement: S104
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2019-05-23
Decision code: OK30
Date received: 2019-04-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing move within an approved facility for the Prostar XL Percutaneous Vascular Surgical System and the StarClose SE Vascular Closure System.