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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.
 
DeviceTRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM
Generic Nametissue adhesive for use in embolization of brain arteriovenous malformations
ApplicantCerenovus, Inc.
6303 Waterford District Drive, Suite 315
Miami, FL 33126
PMA NumberP990040
Supplement NumberS022
Date Received04/18/2016
Decision Date06/03/2016
Product Code KGG 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for modified acceptance criteria for n-BCA purity and a control limit for n-BCA dimers.
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