PMA P040044S088

Device
Mynx Control and Mynx Grip Vascular Closure Device
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S088
Product code
MGB
Decision date
2021-11-05
Generic name
Device, hemostasis, vascular
Approval order statement
Use of an additional supplier for the syringe component used in the MynxGrip and Mynx Control Vascular Closure Devices.

Current openFDA PMA Record#

Device
Mynx Control and Mynx Grip Vascular Closure Device
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S088
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2021-11-05
Decision code
OK30
Date received
2021-10-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use of an additional supplier for the syringe component used in the MynxGrip and Mynx Control Vascular Closure Devices.