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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
ApplicantCOVIDIEN
PMA NumberP040034
Supplement NumberS015
Date Received10/26/2009
Decision Date11/25/2009
Product Code
NQR[ Registered Establishments with NQR ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the number of trays in the depyrogenation oven and the vial capping machine.
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