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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 | S021 |
Date Received | 08/28/2015 |
Decision Date | 09/25/2015 |
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 REMOVAL OF THE INCOMING INSPECTION REQUIREMENT FOR PERFORMING MATERIAL IDENTIFICATION VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) TESTING ON THE N-BCA SELF-PIERCING CAPS. REDUCE THE SAMPLING REQUIREMENT FOR THE VISUAL APPEARANCE INSPECTION OF THE N-BCA. |