PMA P990040S016
- Device
- TRUFILL N-BUTYLCYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S016
- Product code
- KGG
- Decision date
- 2010-12-22
- 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
- IMPLEMENTATION OF A PARAMETRIC RELEASE PROCESS FOR ETHYLENE OXIDE STERILIZED PRODUCTS.
Current openFDA PMA Record#
- Device
- TRUFILL N-BUTYLCYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S016
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2010-12-22
- Decision code
- OK30
- Date received
- 2010-11-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF A PARAMETRIC RELEASE PROCESS FOR ETHYLENE OXIDE STERILIZED PRODUCTS.