PMA P930038S080

Device
ANGIO-SEAL VASCULAR CLOSURE DEVICE
Applicant
Terumo Medical Corporation
PMA number
P930038
Supplement
S080
Product code
MGB
Decision date
2016-04-25
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
Automate the puncture locator and sheath annealing cycle verification process.

Current openFDA PMA Record#

Device
ANGIO-SEAL VASCULAR CLOSURE DEVICE
Applicant
Terumo Medical Corporation
PMA number
P930038
Supplement
S080
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2016-04-25
Decision code
OK30
Date received
2016-03-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Automate the puncture locator and sheath annealing cycle verification process.