PMA supplement
P900009 S018: EXOGEN 2000+ AND EXOGEN 3000
FDA PMA supplement · Real-Time Process · Bioventus, LLC
Key facts
| Original PMA | P900009 |
|---|---|
| Supplement number | S018 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | EXOGEN 2000+ AND EXOGEN 3000 |
| Generic name | Stimulator, ultrasound and muscle, for use other than applying therapeutic deep |
| Applicant | Bioventus, LLC |
| Product code | LPQ |
| Received date | Jan 29, 2004 |
| Decision date | Mar 12, 2004 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: