PMA P040044S056

Device: MYNXGRIP VASCULAR CLOSURE DEVICE
Applicant: Cordis US Corporation
PMA number: P040044
Supplement: S056
Product code: MGB
Decision date: 2014-07-30
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL TO EXPAND THE INDICATIONS FOR USE TO INCLUDE CLOSURE OF VENOUS ACCESS SITES IN ADDITION TO THE CURRENTLY APPROVED USE FOR CLOSURE OF ARTERIAL ACCESS SITES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYNXGRIP VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE TO SEAL FEMORAL ARTERIAL AND FEMORAL VENOUS ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5F, 6F OR 7F PROCEDURAL SHEATH.

Current openFDA PMA Record#

Device: MYNXGRIP VASCULAR CLOSURE DEVICE
Applicant: Cordis US Corporation
PMA number: P040044
Supplement: S056
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2014-07-30
Decision code: APPR
Date received: 2014-05-02
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO EXPAND THE INDICATIONS FOR USE TO INCLUDE CLOSURE OF VENOUS ACCESS SITES IN ADDITION TO THE CURRENTLY APPROVED USE FOR CLOSURE OF ARTERIAL ACCESS SITES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYNXGRIP VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE TO SEAL FEMORAL ARTERIAL AND FEMORAL VENOUS ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5F, 6F OR 7F PROCEDURAL SHEATH.