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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-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 NumberS030
Date Received11/17/2022
Decision Date02/28/2023
Product Code KGG 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for new manufacturing sites located at: 1) Steris Isomedix Services, 1175 Isuzu Parkway, Grand Prairie, Texas, 75050; 2) Steris Isomedix Services, 7685 St. Andrews Avenue, San Diego, California, 92154; and 3) Sterigenics, 2400 Airport Road, Santa Teresa, New Mexico, 88008. These manufacturing sites will be performing sterilization of the TRUFILL n-BCA Liquid Embolic System.
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