PMA P990040S013
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S013
- Product code
- KGG
- Decision date
- 2010-10-08
- 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 TO CHANGE THE CHEMICAL COMPOSITION TESTING SUPPLIER.
Current openFDA PMA Record#
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S013
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2010-10-08
- Decision code
- APPR
- Date received
- 2010-08-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO CHANGE THE CHEMICAL COMPOSITION TESTING SUPPLIER.