TRUFILL n-BCA Liquid Embolic System (LES), TRUFILL n-BCA Liquid Embolic System Procedural Set
FDA premarket approval P990040/S034 · decided 2025-12-16
Approval details
- PMA number
- P990040
- Supplement
- S034
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TRUFILL n-BCA Liquid Embolic System (LES), TRUFILL n-BCA Liquid Embolic System Procedural Set
- Generic name
- Neurovascular Liquid Embolic Agent
- Applicant
- Cerenovus, Inc.
- Date received
- 2025-02-03
- Decision date
- 2025-12-16
- Days to decision
- 316 days
- Decision code
- APPR
- Product code
- SGU
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Miami, FL
- Statement
- The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired and for embolization of the Middle Meningeal Artery (MMA) for the treatment of symptomatic subacute and chronic Subdural Hematoma (SDH) as an adjunct to surgery.
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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 |