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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 NameDURASEAL DURAL SEALANT SYSTEM
Classification Namesealant, dural
Generic Namesurgical sealant,polymerizing
ApplicantCONFLUENT SURGICAL,INC
PMA NumberP040034
Supplement NumberS004
Date Received06/08/2006
Decision Date08/02/2006
Product Code
NQR[ Registered Establishments with NQR ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) use of nof corporation as an alternate vendor for functionalizing raw peg-polyol material to peg-sg for use in the duraseal dural sealant product, and 2) implementation of an in-process particle size inspection step prior to the milling step.
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