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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.
Classification Namesealant, dural
Generic Namesurgical sealant,polymerizing
PMA NumberP040034
Supplement NumberS016
Date Received01/11/2010
Decision Date05/28/2010
Product Code
NQR[ Registered Establishments with NQR ]
Advisory Committee Neurology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to update the contents of the duraseal package insert based on the results of the post-approval study.