PMA P990040S014
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S014
- Product code
- KGG
- Decision date
- 2010-11-10
- 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
- CHANGE IN: 1) SUPPLIER OF THE ETHIODIZED OIL COMPONENT OF THE N-BCA LIQUID EMBOLIC SYSTEM; AND 2) THE STERILIZATION METHOD FOR THE ETHIODIZED OIL.
Current openFDA PMA Record#
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S014
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2010-11-10
- Decision code
- OK30
- Date received
- 2010-10-12
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE IN: 1) SUPPLIER OF THE ETHIODIZED OIL COMPONENT OF THE N-BCA LIQUID EMBOLIC SYSTEM; AND 2) THE STERILIZATION METHOD FOR THE ETHIODIZED OIL.