Trufill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
FDA premarket approval P990040/S027 · decided 2019-03-22
Approval details
- PMA number
- P990040
- Supplement
- S027
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2018-11-02
- Decision date
- 2019-03-22
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- KGG
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Miami, FL
- Statement
- Approval for a manufacturing site located at Chemence Medical Products, Inc., 200 Technology Drive, Alpharetta, Georgia, for the manufacturing and sterilization of the n-butyl cyanoacrylate (n-BCA) component of the TRUFILL n-BCA Liquid Embolic System.
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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 |