PMA P990040
- Device
- TRUFILL n-BCA Liquid Embolic System
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S029
- Product code
- KGG
- Decision date
- 2026-05-26
- Classification
- Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Approval order statement
- approval for implementation of alternate dry heat sterilization cycle parameters in a dedicated batch oven for TRUFILL n-BCA Liquid Embolization component manufactured and sterilized at Chemence Medical, Inc
Current openFDA PMA Record#
- Device
- TRUFILL n-BCA Liquid Embolic System
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S038
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2026-05-26
- Decision code
- OK30
- Date received
- 2026-04-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for implementation of alternate dry heat sterilization cycle parameters in a dedicated batch oven for TRUFILL n-BCA Liquid Embolization component manufactured and sterilized at Chemence Medical, Inc