PMA
P130019: MAESTRO RECHARGEABLE SYSTEM
FDA PMA · Neuromodulator for obesity · Reshape Lifesciences, Inc.
Key facts
| PMA number | P130019 |
|---|---|
| Trade name | MAESTRO RECHARGEABLE SYSTEM |
| Generic name | Neuromodulator for obesity |
| Applicant | Reshape Lifesciences, Inc. |
| Owner/operator | Medtimo, Inc. |
| Product code | PIM |
| Approval date | Jan 14, 2015 |
| Docket number | 15M-0201 |
| Notice date | Jan 16, 2015 |
| Establishment registration | 3013508647 |
| FEI number | 3013508647 |
At a glance
- 10–99 Supplements
- Feb 15, 2019 Latest supplement decision
- Yes Withdrawn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: