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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
St. Jude Medical, Inc.
6500 wedgwood rd.
maple grove, MN 55311
PMA NumberP020035
Date Received09/03/2002
Decision Date09/30/2003
Withdrawal Date 11/04/2010
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 09M-0406
Notice Date 09/25/2009
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the x-press 6 french vascular closure system. The device is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures using sheaths less than or equal to 6 french in size. The device is intended to reduce the time to hemostasis, time to ambulation (100 feet), and time to dischargeability in patients who have undergone diagnostic or interventional cardiac catheterization procedures without complicating clinical conditions, including those patients receiving glycoprotein iib/iiia inhibitors.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002