PMA
P210016: ManaFuse
FDA PMA · Stimulator, bone growth, non-invasive · Enovis
Key facts
| PMA number | P210016 |
|---|---|
| Trade name | ManaFuse |
| Generic name | Stimulator, bone growth, non-invasive |
| Applicant | Enovis |
| Owner/operator | ManaMed LLC |
| Product code | LOF |
| Approval date | Jan 17, 2025 |
| Docket number | 25M-0285 |
| Establishment registration | 3011767724 |
| FEI number | 3011767724 |
At a glance
- None Supplements
- Jan 17, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: