PMA P100013S006

Device
EXOSEAL VASCULAR CLOSURE DEVICE
Applicant
Cordis US Corporation
PMA number
P100013
Supplement
S006
Product code
MGB
Decision date
2012-10-12
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
AN ALTERNATE TOOL FOR POSITIONING A COMPONENT AND THE ADDITION OF TWO OPTICAL SENSORS.

Current openFDA PMA Record#

Device
EXOSEAL VASCULAR CLOSURE DEVICE
Applicant
Cordis US Corporation
PMA number
P100013
Supplement
S006
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2012-10-12
Decision code
OK30
Date received
2012-09-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
AN ALTERNATE TOOL FOR POSITIONING A COMPONENT AND THE ADDITION OF TWO OPTICAL SENSORS.