PMA P040044S047

Device: MYNX ACE VASCULAR CLOSURE DEVICE (6F/7F)
Applicant: Cordis US Corporation
PMA number: P040044
Supplement: S047
Product code: MGB
Decision date: 2013-08-19
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE DELIVERY SYSTEM THAT COMPOSES THE MYNXGRIP VASCULAR CLOSURE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYNX ACE VASCULAR CLOSURE DEVICE ("MYNX ACE") AND IS INDICATED FOR USE TO SEAL FEMORAL ARTERIALACCESS 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: MYNX ACE VASCULAR CLOSURE DEVICE (6F/7F)
Applicant: Cordis US Corporation
PMA number: P040044
Supplement: S047
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2013-08-19
Decision code: APPR
Date received: 2012-12-31
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE DELIVERY SYSTEM THAT COMPOSES THE MYNXGRIP VASCULAR CLOSURE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYNX ACE VASCULAR CLOSURE DEVICE ("MYNX ACE") AND IS INDICATED FOR USE TO SEAL FEMORAL ARTERIALACCESS 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.