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. |
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Device | TRUFILL(R) 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 | S001 |
Date Received | 03/01/2001 |
Decision Date | 05/30/2001 |
Product Code |
KGG |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REMOVAL OF THE POST ETHYLENE OXIDE STERILIZATION PYROGEN TEST OF THE N-BCA, REMOVAL OF THE POST-STERILIZATION FUNCTIONAL TESTING OF THE TANTALUM POWDER, THE ADDITION OF A PYROGEN TEST OF THE TANTALUM POWDER, AND THE VALIDATION OF THE PYROGENICITY TEST. |
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