PMA P990040S036
- Device
- TRUFILL n-BCA Liquid Embolic System
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S036
- Product code
- KGG
- Decision date
- 2025-08-22
- Classification
- Neurology
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Approval order statement
- approval for an alternative identification method for the ethiodized oil component
Current openFDA PMA Record#
- Device
- TRUFILL n-BCA Liquid Embolic System
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S036
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2025-08-22
- Decision code
- OK30
- Date received
- 2025-07-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for an alternative identification method for the ethiodized oil component