PMA P990040S017

Device
TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
Applicant
Cerenovus, Inc.
PMA number
P990040
Supplement
S017
Product code
KGG
Decision date
2013-12-24
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 TO CHANGE THE SUPPLIER FOR A CHEMICAL COMPOSITION TEST.
Summary
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Current openFDA PMA Record#

Device
TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
Applicant
Cerenovus, Inc.
PMA number
P990040
Supplement
S017
Product code
KGG
Generic name
tissue adhesive for use in embolization of brain arteriovenous malformations
Decision date
2013-12-24
Decision code
APPR
Date received
2013-09-16
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL TO CHANGE THE SUPPLIER FOR A CHEMICAL COMPOSITION TEST.