|
Device | TransPyloric Shuttle/TransPyloric Shuttle Delivery Device |
Generic Name | implant, intragastric for morbid obesity |
Applicant |
BAROnova, Inc |
1509 industrial road |
san carlos, CA 94070 |
|
PMA Number | P180024 |
Date Received | 07/09/2018 |
Decision Date | 04/16/2019 |
Product Code |
LTI
|
Docket Number | 19M-1848 |
Notice Date | 04/18/2019 |
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 Study | Show Report Schedule and Study Progress |
Supplements: |
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