PMA P050007S009

Device

STARCLOSE AND STARCLOSE SE VASCULAR CLOSURE SYSTEMS

Applicant

Abbott Vascular Devices

PMA number

P050007

Supplement

S009

Product code

MGB

Decision date

2008-08-25

Classification

Device, Hemostasis, Vascular

Generic name

Device, hemostasis, vascular

Approval order statement

APPROVAL FOR MODIFICATIONS TO THE INDICATIONS FOR USE. THE DEVICE, AS MODIFIED, WILL BE INDICATED FOR THE FOLLOWING: THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS, AMBULATION, AND DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH. THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR USE TO ALLOW PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES TO AMBULATE AND BE ELIGIBLE FOR DISCHARGE AS SOON AS POSSIBLE AFTER DEVICE PLACEMENT. THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION, IN PATIENTS WHO HAVE UNDERGONE INTERVENTIONAL ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.

Summary

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