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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 (NBCA) 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 NumberS004
Date Received04/28/2006
Decision Date06/01/2006
Product Code KGG 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REVISIONS TO THE PRODUCT LABEL REGARDING USE OF THE PRODUCT UNDER HIGH FLOW CONDITIONS, AND WITH RATIOS OF CONTRAST REAGENT AND NBCA OUTSIDE OF THOSE RATIOS TESTED IN THE CLINICAL STUDY.
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