FDA.reportPublic FDA data

PMA P930038S092

Device
Angio-Seal Vascular Closure Devices
Applicant
Terumo Medical Corporation
PMA number
P930038
Supplement
S092
Product code
MGB
Decision date
2019-03-21
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
Transferring the procurement of, and receiving inspection activities for, certain components and raw materials used to manufacture ANGIO-SEAL VIP and STS Plus devices from Abbott to Terumo Puerto Rico.

Current openFDA PMA Record#

Device
Angio-Seal Vascular Closure Devices
Applicant
Terumo Medical Corporation
PMA number
P930038
Supplement
S092
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2019-03-21
Decision code
OK30
Date received
2019-02-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Transferring the procurement of, and receiving inspection activities for, certain components and raw materials used to manufacture ANGIO-SEAL VIP and STS Plus devices from Abbott to Terumo Puerto Rico.