PMA supplement
P900009 S013: EXOGEN 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R))
FDA PMA supplement · Normal 180 Day Track · Bioventus, LLC
Key facts
| Original PMA | P900009 |
|---|---|
| Supplement number | S013 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | EXOGEN 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R)) |
| Generic name | Stimulator, ultrasound and muscle, for use other than applying therapeutic deep |
| Applicant | Bioventus, LLC |
| Product code | LPQ |
| Received date | Apr 30, 2001 |
| Decision date | Sep 4, 2001 |
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: