FDA.reportPublic FDA data

PMA P930038S087

Device
Angio Seal Vascular Closure Devices
Applicant
Terumo Medical Corporation
PMA number
P930038
Supplement
S087
Product code
MGB
Decision date
2018-04-03
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
Modification to the sterilizer isotope for the AngioSeal Evolution, STS Plus, and VIP devices and a change to the AngioSeal STS Plus and VIP load configuration.

Current openFDA PMA Record#

Device
Angio Seal Vascular Closure Devices
Applicant
Terumo Medical Corporation
PMA number
P930038
Supplement
S087
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2018-04-03
Decision code
OK30
Date received
2018-03-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification to the sterilizer isotope for the AngioSeal Evolution, STS Plus, and VIP devices and a change to the AngioSeal STS Plus and VIP load configuration.