PMA P990040S015
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S015
- Product code
- KGG
- Decision date
- 2011-01-26
- 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 MINOR PACKAGING AND LABELING CHANGES RELATED TO THE REPLACEMENT OF ETHODIZED OIL WITH LIPIODOL AS A DEVICE COMPONENT FOR USE IN THE TRUFILL N-BUTYL CYANOACRYLATE (NBCA) LIQUID EMBOLIC SYSTEM.
Current openFDA PMA Record#
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S015
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2011-01-26
- Decision code
- APPR
- Date received
- 2010-11-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MINOR PACKAGING AND LABELING CHANGES RELATED TO THE REPLACEMENT OF ETHODIZED OIL WITH LIPIODOL AS A DEVICE COMPONENT FOR USE IN THE TRUFILL N-BUTYL CYANOACRYLATE (NBCA) LIQUID EMBOLIC SYSTEM.