PMA supplement
P850007 S006: AME BONE GROWTH STIMULATOR
FDA PMA supplement · Panel Track · Orthofix, Inc.
Key facts
| Original PMA | P850007 |
|---|---|
| Supplement number | S006 |
| Supplement type | Panel Track |
| Reason for the supplement | Other |
| Trade name | AME BONE GROWTH STIMULATOR |
| Generic name | Stimulator, bone growth, non-invasive |
| Applicant | Orthofix, Inc. |
| Product code | LOF |
| Received date | Jun 6, 1988 |
| Decision date | Feb 7, 1990 |
| Docket number | 90M-0067 |
| Notice date | Mar 8, 1990 |
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: