PMA P040044S082

Device
MynxGrip Vascular Closure Device, Mynx Ace Vascular Closure Device
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S082
Product code
MGB
Decision date
2018-09-06
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
Implementation of an additional freeze dryer.

Current openFDA PMA Record#

Device
MynxGrip Vascular Closure Device, Mynx Ace Vascular Closure Device
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S082
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2018-09-06
Decision code
OK30
Date received
2018-08-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of an additional freeze dryer.