TransPyloric Shuttle/TransPyloric Shuttle Delivery Device
FDA premarket approval P180024 · decided 2019-04-16
Approval details
- PMA number
- P180024
- Trade name
- TransPyloric Shuttle/TransPyloric Shuttle Delivery Device
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Baronova, Inc.
- Date received
- 2018-07-09
- Decision date
- 2019-04-16
- Days to decision
- 281 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- San Carlos, CA
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BAROnova Access Sheath Kit (K191078) | Baronova, Inc. | 2019-07-22 |
| BAROnova Insufflation System, BAROnova Accessory Kit (K190985) | Baronova, Inc. | 2019-05-14 |
| BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap (K172575) | Baronova, Inc. | 2018-01-18 |