PMA P180024
- Device
- TransPyloric Shuttle/TransPyloric Shuttle Delivery Device
- Applicant
- Baronova, Inc.
- PMA number
- P180024
- Product code
- LTI
- Decision date
- 2019-04-16
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf18/P180024B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- TransPyloric Shuttle/TransPyloric Shuttle Delivery Device
- Applicant
- Baronova, Inc.
- PMA number
- P180024
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2019-04-16
- Decision code
- APPR
- Date received
- 2018-07-09
- 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.