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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 | S019 |
Date Received | 09/17/2014 |
Decision Date | 11/05/2014 |
Product Code |
KGG |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO REPLACE THE CURRENT STERILE POUCH FOR THE TRUFILL®N-BCA AND THE TANTALUM POWDER COMPONENTS WITH A NEW STERILE POUCH OF THE SAME MATERIALS AS THE EXISTING POUCH WITH A NEW POUCH COATING AND NEW THUMB NOTCHES AND IS SOURCED FROM A NEW VENDOR, OLIVER-TOLAS HEALTHCARE PRODUCTS. |