FDA.reportPublic FDA data

PMA P930038S094

Device
ANGIO-SEAL Vascular Closure Devices
Applicant
Terumo Medical Corporation
PMA number
P930038
Supplement
S094
Product code
MGB
Decision date
2019-04-19
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
New testing facilities for quarterly bioburden monitoring, a new testing facility for sample pre-sterilization preparation, and a new testing facility for sterility testing.

Current openFDA PMA Record#

Device
ANGIO-SEAL Vascular Closure Devices
Applicant
Terumo Medical Corporation
PMA number
P930038
Supplement
S094
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2019-04-19
Decision code
OK30
Date received
2019-03-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New testing facilities for quarterly bioburden monitoring, a new testing facility for sample pre-sterilization preparation, and a new testing facility for sterility testing.