PMA P040044S048

Device: MYNXCADENCE AND MYNXGRIP VASCULAR DEVICES
Applicant: Cordis US Corporation
PMA number: P040044
Supplement: S048
Product code: MGB
Decision date: 2013-05-17
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR CLARIFICATION AND SIMPLIFICATION OF THE LANGUAGE USED INTHE INSTRUCTION FOR USE AND REMOVAL OF THE STERILIZATION INDICATOR LABEL FROM THE DEVICE POUCH FOR THE MYNX CADENCE VASCULAR CLOSURE DEVICE, 6F/7F MYNXGRIP VASCULAR CLOSURE DEVICE, AND 5F MYNXGRIP VASCULAR CLOSURE DEVICE.

Current openFDA PMA Record#

Device: MYNXCADENCE AND MYNXGRIP VASCULAR DEVICES
Applicant: Cordis US Corporation
PMA number: P040044
Supplement: S048
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2013-05-17
Decision code: APPR
Date received: 2013-02-22
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CLARIFICATION AND SIMPLIFICATION OF THE LANGUAGE USED INTHE INSTRUCTION FOR USE AND REMOVAL OF THE STERILIZATION INDICATOR LABEL FROM THE DEVICE POUCH FOR THE MYNX CADENCE VASCULAR CLOSURE DEVICE, 6F/7F MYNXGRIP VASCULAR CLOSURE DEVICE, AND 5F MYNXGRIP VASCULAR CLOSURE DEVICE.