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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameX-PRESS TRIMMER - ACCESSORY TO THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantDATASCOPE CORP.
PMA NumberP020035
Supplement NumberS001
Date Received11/07/2003
Decision Date12/18/2003
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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