PMA P930038S095

Device: Angio-Seal Vascular Closure Devices
Applicant: Terumo Medical Corporation
PMA number: P930038
Supplement: S095
Product code: MGB
Decision date: 2019-05-23
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: Transfer the procurement of, and receiving inspection activities for, certain components and raw materials used to manufacture ANGIO-SEAL Evolution devices from Abbott to Terumo Puerto Rico (TPR).

Current openFDA PMA Record#

Device: Angio-Seal Vascular Closure Devices
Applicant: Terumo Medical Corporation
PMA number: P930038
Supplement: S095
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2019-05-23
Decision code: OK30
Date received: 2019-04-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Transfer the procurement of, and receiving inspection activities for, certain components and raw materials used to manufacture ANGIO-SEAL Evolution devices from Abbott to Terumo Puerto Rico (TPR).