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Device | TRUFILL N-BUTYL CYANOACRYLATE 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 |
Date Received | 07/16/1999 |
Decision Date | 09/25/2000 |
Product Code |
KGG |
Docket Number | 00M-1569 |
Notice Date | 10/20/2000 |
Advisory Committee |
Neurology |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE TRUFILL(R) N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM. THE DEVICE IS INDICATED FOR THE EMBOLIZATION OF CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS) WHEN PRESURGICAL DEVASCULARIZATION IS DESIRED. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 S030 S031 S032 |