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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 NumberS001
Date Received09/02/2005
Decision Date10/25/2005
Product Code
NQR[ Registered Establishments with NQR ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an extension of the product expiration date to 18 months.
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