PMA P990040S004
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (NBCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S004
- Product code
- KGG
- Decision date
- 2006-06-01
- 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 REVISIONS TO THE PRODUCT LABEL REGARDING USE OF THE PRODUCT UNDER HIGH FLOW CONDITIONS, AND WITH RATIOS OF CONTRAST REAGENT AND NBCA OUTSIDE OF THOSE RATIOS TESTED IN THE CLINICAL STUDY.
Current openFDA PMA Record#
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (NBCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S004
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2006-06-01
- Decision code
- APPR
- Date received
- 2006-04-28
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISIONS TO THE PRODUCT LABEL REGARDING USE OF THE PRODUCT UNDER HIGH FLOW CONDITIONS, AND WITH RATIOS OF CONTRAST REAGENT AND NBCA OUTSIDE OF THOSE RATIOS TESTED IN THE CLINICAL STUDY.