PMA P990040S009
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S009
- Product code
- KGG
- Decision date
- 2010-02-25
- 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 MANUFACTURING SITES LOCATED AT CODMAN & SHURTLEFF, INC. IN RAYNHAM, MASSACHUSETTS AND BRIDGEWATER, MASSACHUSETTS.
Current openFDA PMA Record#
- Device
- TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
- Applicant
- Cerenovus, Inc.
- PMA number
- P990040
- Supplement
- S009
- Product code
- KGG
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Decision date
- 2010-02-25
- Decision code
- APPR
- Date received
- 2009-08-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR MANUFACTURING SITES LOCATED AT CODMAN & SHURTLEFF, INC. IN RAYNHAM, MASSACHUSETTS AND BRIDGEWATER, MASSACHUSETTS.