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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 NumberS005
Date Received06/13/2006
Decision Date09/15/2006
Product Code NQR 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A STERILIZATION SITE LOCATED AT BEAMONE LLC, LIMA, OHIO.
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