PMA P040044S063

Device
MYNXGRIP VASCULAR CLOSURE DEVICE
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S063
Product code
MGB
Decision date
2015-04-24
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
CHANGE THE BALLOON MATERIAL RESIN OF THE MYNXGRIP VASCULAR CLOSURE DEVICE.

Current openFDA PMA Record#

Device
MYNXGRIP VASCULAR CLOSURE DEVICE
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S063
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2015-04-24
Decision code
OK30
Date received
2015-03-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE THE BALLOON MATERIAL RESIN OF THE MYNXGRIP VASCULAR CLOSURE DEVICE.