PMA
P180024: TransPyloric Shuttle/TransPyloric Shuttle Delivery Device
FDA PMA · IMPLANT, INTRAGASTRIC FOR MORBID OBESITY · Baronova, Inc.
Key facts
| PMA number | P180024 |
|---|---|
| Trade name | TransPyloric Shuttle/TransPyloric Shuttle Delivery Device |
| Generic name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
| Applicant | Baronova, Inc. |
| Product code | LTI |
| Approval date | Apr 16, 2019 |
| Docket number | 19M-1848 |
| Notice date | Apr 18, 2019 |
| FEI number | 3012573149 |
At a glance
- None Supplements
- Apr 16, 2019 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: