PMA P990040S006
- Device
- TRUFIL N-BCA LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S006
- Product code
- KGG
- Decision date
- 2007-11-30
- 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
- CHANGE TO THE BIOLOGICAL INDICATORS USED TO MONITOR THE ETHYLENE OXIDE STERILIZATION CYCLES (USE OF A SELF CONTAINED BIOLOGICAL INDICATOR IN PLACE OF A SPORE STRIP BIOLOGICAL INDICATOR).
Current openFDA PMA Record#
- Device
- TRUFIL N-BCA LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S006
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2007-11-30
- Decision code
- OK30
- Date received
- 2007-11-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE BIOLOGICAL INDICATORS USED TO MONITOR THE ETHYLENE OXIDE STERILIZATION CYCLES (USE OF A SELF CONTAINED BIOLOGICAL INDICATOR IN PLACE OF A SPORE STRIP BIOLOGICAL INDICATOR).