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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 (N-BCA) LIQUID EMBOLIC SYSTEM.
Generic Nametissue adhesive for use in embolization of brain arteriovenous malformations
ApplicantCerenovus, Inc.
6303 Waterford District Dr.
Suite 315
Miami, FL 33126
PMA NumberP990040
Supplement NumberS021
Date Received08/28/2015
Decision Date09/25/2015
Product Code KGG 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
REMOVAL OF THE INCOMING INSPECTION REQUIREMENT FOR PERFORMING MATERIAL IDENTIFICATION VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) TESTING ON THE N-BCA SELF-PIERCING CAPS. REDUCE THE SAMPLING REQUIREMENT FOR THE VISUAL APPEARANCE INSPECTION OF THE N-BCA.
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