PMA P990040S012
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S012
- Product code
- KGG
- Decision date
- 2010-09-27
- 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 RELABELING AND REPACKAGING THE ETHIODIZED OIL COMPONENT TO MEET THE CURRENT CODMAN SPECIFICATION.
Current openFDA PMA Record#
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S012
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2010-09-27
- Decision code
- APPR
- Date received
- 2010-07-28
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR RELABELING AND REPACKAGING THE ETHIODIZED OIL COMPONENT TO MEET THE CURRENT CODMAN SPECIFICATION.