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.
| Device | TransPyloric Shuttle/TransPyloric Shuttle Delivery |
| Classification Name | Implant, Intragastric For Morbid Obesity |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | BAROnova, Inc |
| Date Received | 2018-07-09 |
| Decision Date | 2019-04-16 |
| PMA | P180024 |
| Supplement | S |
| Product Code | LTI |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAROnova, Inc 1509 Industrial Road san Carlos, CA 94070 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180024 | Original Filing |