PMA P040044S066

Device
MYNXGRIP VASCULAR CLOSURE DEVICE (MYNXGRIP)
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S066
Product code
MGB
Decision date
2015-12-03
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
APPROVAL FOR AN EXTENSION OF SHELF LIFE FROM ONE YEAR TO TWO YEARS.

Current openFDA PMA Record#

Device
MYNXGRIP VASCULAR CLOSURE DEVICE (MYNXGRIP)
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S066
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2015-12-03
Decision code
APPR
Date received
2015-09-09
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR AN EXTENSION OF SHELF LIFE FROM ONE YEAR TO TWO YEARS.