PMA P990040S023
- Device
- TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S023
- Product code
- KGG
- Decision date
- 2016-12-14
- 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
- Acceptance for a manufacturing equipment/process change involving the dosimetry system at STERIS, the contract sterilizer for the Codman TRUFILL n-Butyl Cyanoacrylate Liquid Embolic System.
Current openFDA PMA Record#
- Device
- TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S023
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2016-12-14
- Decision code
- OK30
- Date received
- 2016-11-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Acceptance for a manufacturing equipment/process change involving the dosimetry system at STERIS, the contract sterilizer for the Codman TRUFILL n-Butyl Cyanoacrylate Liquid Embolic System.