PMA P990040S027
- Device
- Trufill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S027
- Product code
- KGG
- Decision date
- 2019-03-22
- 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 a manufacturing site located at Chemence Medical Products, Inc., 200 Technology Drive, Alpharetta, Georgia, for the manufacturing and sterilization of the n-butyl cyanoacrylate (n-BCA) component of the TRUFILL n-BCA Liquid Embolic System.
Current openFDA PMA Record#
- Device
- Trufill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S027
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2019-03-22
- Decision code
- APPR
- Date received
- 2018-11-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Chemence Medical Products, Inc., 200 Technology Drive, Alpharetta, Georgia, for the manufacturing and sterilization of the n-butyl cyanoacrylate (n-BCA) component of the TRUFILL n-BCA Liquid Embolic System.