PMA P040044S087

Device
MynxGrip Vascular Closure Device (VCD)
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S087
Product code
MGB
Decision date
2021-11-03
Generic name
Device, hemostasis, vascular
Approval order statement
Use of an alternate syringe supplier for the syringe packaged with the MynxGrip Vascular Closure Device (VCD).

Current openFDA PMA Record#

Device
MynxGrip Vascular Closure Device (VCD)
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S087
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2021-11-03
Decision code
OK30
Date received
2021-10-07
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 MynxGrip Vascular Closure Device (VCD).