PMA P930038S093

Device
Angio Seal Vascular Closure Devices
Applicant
Terumo Medical Corporation
PMA number
P930038
Supplement
S093
Product code
MGB
Decision date
2019-03-29
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
Transfer the Angio-Seal Evolution product line manufacturing from Minnetonka to Caguas, Puerto Rico.

Current openFDA PMA Record#

Device
Angio Seal Vascular Closure Devices
Applicant
Terumo Medical Corporation
PMA number
P930038
Supplement
S093
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2019-03-29
Decision code
OK30
Date received
2019-02-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Transfer the Angio-Seal Evolution product line manufacturing from Minnetonka to Caguas, Puerto Rico.