PMA P040044S052

Device
MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S052
Product code
MGB
Decision date
2014-04-30
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
REDUCTION IN THE POUCH SEAL SAMPLING PLAN.

Current openFDA PMA Record#

Device
MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S052
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2014-04-30
Decision code
OK30
Date received
2014-03-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
REDUCTION IN THE POUCH SEAL SAMPLING PLAN.