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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(R) N-BUTYL CYANOACRYLATE (N-BCA) 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 NumberS001
Date Received03/01/2001
Decision Date05/30/2001
Product Code KGG 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REMOVAL OF THE POST ETHYLENE OXIDE STERILIZATION PYROGEN TEST OF THE N-BCA, REMOVAL OF THE POST-STERILIZATION FUNCTIONAL TESTING OF THE TANTALUM POWDER, THE ADDITION OF A PYROGEN TEST OF THE TANTALUM POWDER, AND THE VALIDATION OF THE PYROGENICITY TEST.
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