PMA
P160001: OBALON BALLOON SYSTEM
FDA PMA · IMPLANT, INTRAGASTRIC FOR MORBID OBESITY · Medtimo, Inc.
Key facts
| PMA number | P160001 |
|---|---|
| Trade name | OBALON BALLOON SYSTEM |
| Generic name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
| Applicant | Medtimo, Inc. |
| Owner/operator | Medtimo, Inc. |
| Product code | LTI |
| Approval date | Sep 8, 2016 |
| Docket number | 16M-2651 |
| Notice date | Sep 14, 2016 |
| Establishment registration | 3013508647 |
| FEI number | 3013508647 |
At a glance
- 10–99 Supplements
- Jul 18, 2022 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: