PMA P990040S019
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S019
- Product code
- KGG
- Decision date
- 2014-11-05
- 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 REPLACE THE CURRENT STERILE POUCH FOR THE TRUFILL®N-BCA AND THE TANTALUM POWDER COMPONENTS WITH A NEW STERILE POUCH OF THE SAME MATERIALS AS THE EXISTING POUCH WITH A NEW POUCH COATING AND NEW THUMB NOTCHES AND IS SOURCED FROM A NEW VENDOR, OLIVER-TOLAS HEALTHCARE PRODUCTS.
Current openFDA PMA Record#
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S019
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2014-11-05
- Decision code
- APPR
- Date received
- 2014-09-17
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO REPLACE THE CURRENT STERILE POUCH FOR THE TRUFILL®N-BCA AND THE TANTALUM POWDER COMPONENTS WITH A NEW STERILE POUCH OF THE SAME MATERIALS AS THE EXISTING POUCH WITH A NEW POUCH COATING AND NEW THUMB NOTCHES AND IS SOURCED FROM A NEW VENDOR, OLIVER-TOLAS HEALTHCARE PRODUCTS.