PMA P990040S007
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S007
- Product code
- KGG
- Decision date
- 2009-02-06
- 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
- CHANGES AND MODIFICATIONS AS FOLLOWS: 1) THE TRANSFER OF THE MANUFACTURING OF THE TRUFILL N-BCA LIQUID EMBOLIC SYSTEM FROMONE BUILDING TO ANOTHER WITHIN THE SAME FACILITY;2) A CLARIFICATION OF THE INSTRUCTIONS FOR USE (1FU)THE REMOVAL OF A REDUNDANT INCOMING RECEIVING INSPECTION FOR THE N-BCA AND TANTALUMPOUCH;3) THE REMOVAL OF A SPECIFICATION FOR THE N-BCA AND TANTALUM POUCH; AND4) MODIFICATION OF THE SEAL SPECIFICATIONS FOR THE N-BCA AND TANTALUM POUCH.
Current openFDA PMA Record#
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S007
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2009-02-06
- Decision code
- OK30
- Date received
- 2008-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES AND MODIFICATIONS AS FOLLOWS: 1) THE TRANSFER OF THE MANUFACTURING OF THE TRUFILL N-BCA LIQUID EMBOLIC SYSTEM FROMONE BUILDING TO ANOTHER WITHIN THE SAME FACILITY;2) A CLARIFICATION OF THE INSTRUCTIONS FOR USE (1FU)THE REMOVAL OF A REDUNDANT INCOMING RECEIVING INSPECTION FOR THE N-BCA AND TANTALUMPOUCH;3) THE REMOVAL OF A SPECIFICATION FOR THE N-BCA AND TANTALUM POUCH; AND4) MODIFICATION OF THE SEAL SPECIFICATIONS FOR THE N-BCA AND TANTALUM POUCH.