PMA P040044S091

Device
MYNX Vascular Closure Device
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S091
Product code
MGB
Decision date
2022-04-25
Generic name
Device, hemostasis, vascular
Approval order statement
Addition of an alternate supplier for components of the MYNX® Vascular Closure Device (VCD).

Current openFDA PMA Record#

Device
MYNX Vascular Closure Device
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S091
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2022-04-25
Decision code
OK30
Date received
2022-03-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of an alternate supplier for components of the MYNX® Vascular Closure Device (VCD).