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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE 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
HDE NumberH220001
Supplement NumberS002
Date Received10/25/2023
Decision Date07/17/2024
Product Code
QOM[ Registered Establishments with QOM ]
Advisory Committee General & Plastic Surgery
Clinical Trials NCT00534664
NCT04327700
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for h220001.
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