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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
Classification Nameimplant, intragastric for morbid obesity
Generic Nameimplant, intragastric for morbid obesity
Applicant
BAROnova, Inc
1509 industrial road
san carlos, CA 94070
PMA NumberP180024
Date Received07/09/2018
Decision Date04/16/2019
Product Code
LTI[ Registered Establishments with LTI ]
Advisory Committee Gastroenterology/Urology
Clinical Trials NCT02518685
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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