PMA P040044S055

Device
THE MYNX VASCULAR CLOSURE DEVICE PRODCUT FAMILY
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S055
Product code
MGB
Decision date
2014-05-08
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
MANUFACTURING PROCESS CHANGES FOR CUTTING AND DRYING THE HYDROGEL CAKES OF THE MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY.

Current openFDA PMA Record#

Device
THE MYNX VASCULAR CLOSURE DEVICE PRODCUT FAMILY
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S055
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2014-05-08
Decision code
OK30
Date received
2014-04-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
MANUFACTURING PROCESS CHANGES FOR CUTTING AND DRYING THE HYDROGEL CAKES OF THE MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY.