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Device | TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System |
Generic Name | tissue adhesive for use in embolization of brain arteriovenous malformations |
Applicant | Cerenovus, Inc. 6303 Waterford District Drive, Suite 315 Miami, FL 33126 |
PMA Number | P990040 |
Supplement Number | S029 |
Date Received | 02/19/2019 |
Decision Date | 09/18/2019 |
Product Code |
KGG |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change to the BHA concentration specified for n-BCA during manufacture, prior to the dry heat sterilization process. |