PMA P930038S098

Device
Angio Seal Vascular Closure Device
Applicant
Terumo Medical Corporation
PMA number
P930038
Supplement
S098
Product code
MGB
Decision date
2020-12-09
Generic name
Device, hemostasis, vascular
Approval order statement
Addition of a new automated printing labeling system and automatic label inspection.

Current openFDA PMA Record#

Device
Angio Seal Vascular Closure Device
Applicant
Terumo Medical Corporation
PMA number
P930038
Supplement
S098
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2020-12-09
Decision code
OK30
Date received
2020-11-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a new automated printing labeling system and automatic label inspection.