PMA P990040S029
- Device
- TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S029
- Product code
- KGG
- Decision date
- 2019-09-18
- 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 a change to the BHA concentration specified for n-BCA during manufacture, prior to the dry heat sterilization process.
Current openFDA PMA Record#
- Device
- TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S029
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2019-09-18
- Decision code
- APPR
- Date received
- 2019-02-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to the BHA concentration specified for n-BCA during manufacture, prior to the dry heat sterilization process.