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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceTransPyloric Shuttle/TransPyloric Shuttle Delivery Device
ApplicantBAROnova, Inc
1509 Industrial Road
San Carlos, CA 94070
PMA NumberP180024
Date Received07/09/2018
Decision Date04/16/2019
Product Code LTI 
Docket Number 19M-1848
Notice Date 04/18/2019
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT02518685
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the TransPyloric Shuttle/TransPyloric Shuttle Delivery Device. The TransPyloric Shuttle/TransPyloric Shuttle Delivery Device is indicated for weight reduction in adult patients with obesity with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more obesity-related comorbid conditions and is intended to be used in conjunction with a diet and behavior modification program.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress