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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTheraBionic P1
Generic Namestimulator, electric field, intrabuccal
Applicant
TheraBionic, Inc.
4108 ryan way
winston-salem, NC 27106-3567
HDE NumberH220001
Date Received09/08/2022
Decision Date09/26/2023
Product Code
QOM[ Registered Establishments with QOM ]
Advisory Committee General & Plastic Surgery
Clinical Trials NCT00534664
NCT04327700
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for therabionic p1:the therabionic p1 medical device is indicated for the treatment of persons ?18 years of age with advanced hepatocellular carcinoma (hcc) who fail first and second line therapy.
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 
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