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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 | S007 |
Date Received | 12/19/2008 |
Decision Date | 02/06/2009 |
Product Code |
KGG |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES AND MODIFICATIONS AS FOLLOWS: 1) THE TRANSFER OF THE MANUFACTURING OF THE TRUFILL N-BCA LIQUID EMBOLIC SYSTEM FROMONE BUILDING TO ANOTHER WITHIN THE SAME FACILITY;2) A CLARIFICATION OF THE INSTRUCTIONS FOR USE (1FU)THE REMOVAL OF A REDUNDANT INCOMING RECEIVING INSPECTION FOR THE N-BCA AND TANTALUMPOUCH;3) THE REMOVAL OF A SPECIFICATION FOR THE N-BCA AND TANTALUM POUCH; AND4) MODIFICATION OF THE SEAL SPECIFICATIONS FOR THE N-BCA AND TANTALUM POUCH. |