PMA P040044S064

Device
5F MYNXGRIP VASCULAR CLOSURE DEVICE (MX5021)
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S064
Product code
MGB
Decision date
2015-07-28
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
MODIFY THE HYDROGEL MANUFACTURING PROCESS.

Current openFDA PMA Record#

Device
5F MYNXGRIP VASCULAR CLOSURE DEVICE (MX5021)
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S064
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2015-07-28
Decision code
OK30
Date received
2015-07-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
MODIFY THE HYDROGEL MANUFACTURING PROCESS.