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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 NumberS003
Date Received05/24/2006
Decision Date11/17/2006
Product Code
NQR[ Registered Establishments with NQR ]
Advisory Committee Neurology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional manufacturing site at millstone medical outsourcing, llc, fall river, massachusetts and an additional sterilization site at beamone, llc, lima, ohio.
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