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 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 | S014 |
Date Received | 10/12/2010 |
Decision Date | 11/10/2010 |
Product Code |
KGG |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE IN: 1) SUPPLIER OF THE ETHIODIZED OIL COMPONENT OF THE N-BCA LIQUID EMBOLIC SYSTEM; AND 2) THE STERILIZATION METHOD FOR THE ETHIODIZED OIL. |
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