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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-PRESS TRIMMER - ACCESSORY TO THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantSt. Jude Medical, Inc.
6500 Wedgwood Rd.
Maple Grove, MN 55311
PMA NumberP020035
Supplement NumberS001
Date Received11/04/2003
Decision Date12/18/2003
Withdrawal Date11/04/2010
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NEW ACCESSORY THAT INCORPORATES THE KNOT PUSHER AND SUTURE CUTTER ACCESSORIES INTO A SINGLE DEVICE. THIS NEWLY CREATED ACCESSORY WILL BE MARKETED UNDER THE TRADE NAME X-PRESS TRIMMER, WHICH ALLOWS THE OPERATOR TO PUSH THE CLINCH KNOT AND CUT THE SUTURE BELOW THE SKIN LINE FOLLOWING THE USE OF THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM.
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