TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
FDA premarket approval P990040/S033 · decided 2024-07-02
Approval details
- PMA number
- P990040
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Applicant
- Cerenovus, Inc.
- Date received
- 2024-04-05
- Decision date
- 2024-07-02
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- KGG
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Miami, FL
- 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
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set (K251828) | Cerenovus, Inc. | 2025-08-22 |
| CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set (K241221) | Cerenovus, Inc. | 2024-10-16 |
| CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter (K241244) | Cerenovus, Inc. | 2024-10-16 |
| CEREGLIDE 92 Catheter System (K233982) | Cerenovus, Inc. | 2024-05-09 |
| Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set (K233988) | Cerenovus, Inc. | 2024-01-17 |
| CEREGLIDE 92 Intermediate Catheter (K230726) | Cerenovus, Inc. | 2023-11-29 |
| CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set (K221934) | Cerenovus, Inc. | 2023-03-09 |
| CEREGLIDE 71 Intermediate Catheter (K221930) | Cerenovus, Inc. | 2023-03-09 |