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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 NumberS007
Date Received08/31/2006
Decision Date11/02/2006
Product Code
NQR[ Registered Establishments with NQR ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of data collected at elevated temperatures (i. E. , accelerated aging data) to determine future shelf life claims for the device, applying a correlation factor of q10=3. The use of the correlation factor with test data obtained at 35 degrees c collected out to 26 weeks accurately predicts product expiration dating to 18 months, real-time.
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