PMA P040044S086

Device
Mynx Control Vascular Closure Device (VCD)
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S086
Product code
MGB
Decision date
2021-09-29
Generic name
Device, hemostasis, vascular
Approval order statement
Use of an alternate syringe supplier for the syringe packaged with the Mynx Control VCD.

Current openFDA PMA Record#

Device
Mynx Control Vascular Closure Device (VCD)
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S086
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2021-09-29
Decision code
OK30
Date received
2021-09-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use of an alternate syringe supplier for the syringe packaged with the Mynx Control VCD.