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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 NumberS002
Date Received01/22/2001
Decision Date03/14/2001
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the instructions for use manual.
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