PMA P990040S026
- Device
- TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S026
- Product code
- KGG
- Decision date
- 2018-06-26
- 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
- Replace the test method and test facility for the n-butyl cyanoacrylate (n-BCA) purity calculation.
Current openFDA PMA Record#
- Device
- TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S026
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2018-06-26
- Decision code
- OK30
- Date received
- 2018-05-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace the test method and test facility for the n-butyl cyanoacrylate (n-BCA) purity calculation.