PMA P990040S002
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (NBCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S002
- Product code
- KGG
- Decision date
- 2006-03-07
- 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
- CHANGE IN THE IMMEDIATE PRODUCT CONTAINER TO ELIMINATE THE WHITE BACKGROUND PAINT FROM THE ALUMINUM TUBE CONTAINING THE PRODUCT.
Current openFDA PMA Record#
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (NBCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S002
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2006-03-07
- Decision code
- OK30
- Date received
- 2006-02-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE IMMEDIATE PRODUCT CONTAINER TO ELIMINATE THE WHITE BACKGROUND PAINT FROM THE ALUMINUM TUBE CONTAINING THE PRODUCT.