PMA P930038S090

Device: Angio Seal Vascular Closure Device
Applicant: Terumo Medical Corporation
PMA number: P930038
Supplement: S090
Product code: MGB
Decision date: 2019-01-17
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: Transfer of bacterial endotoxin testing from the Abbott facility (Plymoth, MN) to the Terumo Puerto Rico facility (Caguas, PR) for ANGIO-SEAL devices manufactured at the Terumo Puerto Rico facility.

Current openFDA PMA Record#

Device: Angio Seal Vascular Closure Device
Applicant: Terumo Medical Corporation
PMA number: P930038
Supplement: S090
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2019-01-17
Decision code: OK30
Date received: 2018-12-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Transfer of bacterial endotoxin testing from the Abbott facility (Plymoth, MN) to the Terumo Puerto Rico facility (Caguas, PR) for ANGIO-SEAL devices manufactured at the Terumo Puerto Rico facility.