PMA P990040S020
- Device
- TRUEFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S020
- Product code
- KGG
- Decision date
- 2015-03-24
- 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 CHANGING THE SUPPLIER AND THE MATERIAL FOR THE N-BUTYL CYANOACRYLATE (N-BCA) CAPS.
Current openFDA PMA Record#
- Device
- TRUEFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S020
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2015-03-24
- Decision code
- APPR
- Date received
- 2015-02-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGING THE SUPPLIER AND THE MATERIAL FOR THE N-BUTYL CYANOACRYLATE (N-BCA) CAPS.