PMA P050007S004

Device

STARCLOSE SE VASCULAR CLOSURE SYSTEM

Applicant

Abbott Vascular Devices

PMA number

P050007

Supplement

S004

Product code

MGB

Decision date

2007-03-23

Classification

Device, Hemostasis, Vascular

Generic name

Device, hemostasis, vascular

Approval order statement

APPROVAL FOR DESIGN CHANGES T THE STARCLOSE VASCULAR CLOSURE SYSTEM (VCS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STARCLOSE SE VASCULAR CLOSURE SYSTEM AND IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION, IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH AND FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIME TO DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.

Summary

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