PMA P040044S113

Device
Cordis Mynx Vascular Closure Portfolio (VCP): MynxGrip, Mynx Control, and Mynx Control Venous Vascular Closure
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S113
Product code
MGB
Decision date
2026-05-14
Classification
Cardiovascular
Generic name
Device, hemostasis, vascular
Approval order statement
the addition of a supplemental patient pamphlet as an optional accompaniment to the Mynx patient brochure

Current openFDA PMA Record#

Device
Cordis Mynx Vascular Closure Portfolio (VCP): MynxGrip, Mynx Control, and Mynx Control Venous Vascular Closure
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S113
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2026-05-14
Decision code
APPR
Date received
2026-04-14
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
the addition of a supplemental patient pamphlet as an optional accompaniment to the Mynx patient brochure