PMA supplement
P910066 S011: ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
FDA PMA supplement · Panel Track · Djo, LLC
Key facts
| Original PMA | P910066 |
|---|---|
| Supplement number | S011 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR |
| Generic name | Stimulator, bone growth, non-invasive |
| Applicant | Djo, LLC |
| Product code | LOF |
| Received date | Aug 20, 1998 |
| Decision date | Dec 17, 1999 |
| Docket number | 00M-1073 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: