PMA P040044S049

Device
MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (MYNX PRODUCT FAMILY)
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S049
Product code
MGB
Decision date
2014-03-28
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
APPROVAL FOR CHANGES TO THE HYDROGEL CONDITIONING CYCLE RECIPE.

Current openFDA PMA Record#

Device
MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (MYNX PRODUCT FAMILY)
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S049
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2014-03-28
Decision code
APPR
Date received
2013-08-14
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR CHANGES TO THE HYDROGEL CONDITIONING CYCLE RECIPE.