PMA P990040S025
- Device
- Codman Trufill N-Butyl Cyanoacrylate Liquid Embolic System
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S025
- Product code
- KGG
- Decision date
- 2017-07-05
- 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
- Implementation of a new sterilization chamber control system at the STERIS, Northborough MA sterilization facility to replace the current system.
Current openFDA PMA Record#
- Device
- Codman Trufill N-Butyl Cyanoacrylate Liquid Embolic System
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S025
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2017-07-05
- Decision code
- OK30
- Date received
- 2017-06-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a new sterilization chamber control system at the STERIS, Northborough MA sterilization facility to replace the current system.