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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDURASEAL DURAL SEALANT SYSTEM
Generic NameSealant, dural
ApplicantIntegra LifeSciences Corporation
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP040034
Supplement NumberS007
Date Received08/24/2006
Decision Date11/02/2006
Product Code NQR 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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