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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 SOLUTION DUETT SEALING DEVICE
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantVASCULAR SOLUTIONS, INC.
PMA NumberP990037
Supplement NumberS008
Date Received12/11/2001
Decision Date05/29/2002
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the delivery cannulae and the procoagulant and changing the buffering agent in the dilutent to tromethamine usp (tris). The device, as modified, will be marketed under the trade name duett flowable hemostat device and is indicated for use as adjunct treatment in obtaining hemostasis in sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture mediated/collagen-based hemostatic devices.
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