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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 NameVASCULAR SOLUTIONS DUETT MODEL 1000 SEALING DEVICE
Generic Namevascular hemostasis device
ApplicantVASCULAR SOLUTIONS, INC.
PMA NumberP990037
Supplement NumberS003
Date Received02/07/2001
Decision Date03/22/2001
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the instructinos for use manual to include the outcome data (registry results) regarding patients treated with platelet gp iib/iiia inhibitors.
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