PMA P990040S001
- Device
- TRUFILL(R) N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S001
- Product code
- KGG
- Decision date
- 2001-05-30
- 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 REMOVAL OF THE POST ETHYLENE OXIDE STERILIZATION PYROGEN TEST OF THE N-BCA, REMOVAL OF THE POST-STERILIZATION FUNCTIONAL TESTING OF THE TANTALUM POWDER, THE ADDITION OF A PYROGEN TEST OF THE TANTALUM POWDER, AND THE VALIDATION OF THE PYROGENICITY TEST.
Current openFDA PMA Record#
- Device
- TRUFILL(R) N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S001
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2001-05-30
- Decision code
- APPR
- Date received
- 2001-03-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Approval order statement
- APPROVAL FOR REMOVAL OF THE POST ETHYLENE OXIDE STERILIZATION PYROGEN TEST OF THE N-BCA, REMOVAL OF THE POST-STERILIZATION FUNCTIONAL TESTING OF THE TANTALUM POWDER, THE ADDITION OF A PYROGEN TEST OF THE TANTALUM POWDER, AND THE VALIDATION OF THE PYROGENICITY TEST.