PMA P930038S089

Device
Angio Seal Vascular Closure Device
Applicant
Terumo Medical Corporation
PMA number
P930038
Supplement
S089
Product code
MGB
Decision date
2018-08-15
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
Transfer the carrier tube component manufacturing process to the Puerto Rico facility.

Current openFDA PMA Record#

Device
Angio Seal Vascular Closure Device
Applicant
Terumo Medical Corporation
PMA number
P930038
Supplement
S089
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2018-08-15
Decision code
OK30
Date received
2018-07-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Transfer the carrier tube component manufacturing process to the Puerto Rico facility.