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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceX-SITE SUTURE-MEDIATED CLOSURE DEVICE
Generic NameDevice, hemostasis, vascular
ApplicantSt. Jude Medical, Inc.
6500 WEDGWOOD RD.
MAPLE GROVE, MN 55311
PMA NumberP020035
Supplement NumberS002
Date Received11/30/2005
Decision Date03/03/2006
Withdrawal Date 11/04/2010
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR VARIOUS LABELING CHANGES AND ERGONOMIC CHANGES TO THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME X-SITE SUTURE-MEDIATED CLOSURE DEVICE AND IS INDICATED FOR ??THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CORONARY CATHETERIZATION PROCEDURES USING SHEATHS LESS THAN OR EQUAL TO 6 FR. THE X-SITE SUTURE-MEDIATED CLOSURE DEVICE IS INTENDED TO REDUCE THE TIME TO H0MOSTASIS, TIME TO AMBULATION (100 FEET), AND TIME TO DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CORONARY CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS, INCLUDING THOSE RECEIVING GLYCOPROTEIN IIB/IIIA INHIBITORS.?
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