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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 NameDUETT PRO SEALING DEVICE, MODEL 1010
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantVASCULAR SOLUTIONS, INC.
PMA NumberP990037
Supplement NumberS028
Date Received10/21/2008
Decision Date12/17/2008
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to extent the shelf life of the sodium phosphate procoagulant diluent, used only in the duet pro sealing device, model 1010, from 2 years to 5 years.
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