PMA P100013S002

Device
EXOSEAL VASCULAR CLOSURE DEVICE
Applicant
Cordis US Corporation
PMA number
P100013
Supplement
S002
Product code
MGB
Decision date
2011-09-27
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
SEVERAL MANUFACTURING CHANGES AT TWO DIFFERENT SUPPLIERS.

Current openFDA PMA Record#

Device
EXOSEAL VASCULAR CLOSURE DEVICE
Applicant
Cordis US Corporation
PMA number
P100013
Supplement
S002
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2011-09-27
Decision code
OK30
Date received
2011-08-30
Supplement type
30-Day Notice
Approval order statement
SEVERAL MANUFACTURING CHANGES AT TWO DIFFERENT SUPPLIERS.