TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
FDA premarket approval P990040/S005 · decided 2007-10-15
Approval details
- PMA number
- P990040
- Supplement
- S005
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process 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
- 2007-07-20
- Decision date
- 2007-10-15
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- KGG
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Miami, FL
- Statement
- APPROVAL FOR A CHANGE IN THE CLEANING PROCESS AND INSPECTION OF PRODUCT CONTAINERS.
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| CEREGLIDE 92 Catheter System (K233982) | Cerenovus, Inc. | 2024-05-09 |
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| 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 |