|
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 | S009 |
Date Received | 08/31/2009 |
Decision Date | 02/25/2010 |
Product Code |
KGG |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MANUFACTURING SITES LOCATED AT CODMAN & SHURTLEFF, INC. IN RAYNHAM, MASSACHUSETTS AND BRIDGEWATER, MASSACHUSETTS. |