PMA P990040S022
- Device
- TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S022
- Product code
- KGG
- Decision date
- 2016-06-03
- 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 modified acceptance criteria for n-BCA purity and a control limit for n-BCA dimers.
Current openFDA PMA Record#
- Device
- TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S022
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2016-06-03
- Decision code
- APPR
- Date received
- 2016-04-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modified acceptance criteria for n-BCA purity and a control limit for n-BCA dimers.