Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
Basic Information
- Device Name
- Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
- Trade Name
- TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
- PMA Number
- P990040
- Supplement Number
- S033
- Device Class
- FDA Class 3
- Product Code
- KGG
- Generic Name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 2, 2024
- Date Received
- April 5, 2024
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
approval for a legal manufacturer change, updates to the Directions for Use (DFU) labeling, and a transition to electronic DFU only with removal of the paper DFU with the packaged devices. The P990040/S033 submission requested to update the legal manufacturer to Cerenovus, Inc.; however, this ownership change was already made under the P990040/A015 submission and acknowledged in the FDA letter dated September 12, 2023, where the legal manufacturer and entity responsible for the PMA was modified from Medos International SARL to Cerenovus, Inc. You also verified by email on April 16, 2024, during the P990040/S033 review that no changes were made to the sites where manufacturing of the TRUFILL n-BCA Liquid Embolic System is performed due to the ownership change.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KGG | Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations | FDA class 3 | Unknown |