PMA P040044S072

Device
MATRIX VASCULAR CLOSURE SYSTEM (VSG)
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S072
Product code
MGB
Decision date
2016-05-04
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
Modify the balloon material resin of the MynxAce balloon catheter.

Current openFDA PMA Record#

Device
MATRIX VASCULAR CLOSURE SYSTEM (VSG)
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S072
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2016-05-04
Decision code
OK30
Date received
2016-04-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modify the balloon material resin of the MynxAce balloon catheter.