PMA supplement
P910066 S028: OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS
FDA PMA supplement · Special (Immediate Track) · Djo, LLC
Key facts
| Original PMA | P910066 |
|---|---|
| Supplement number | S028 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS |
| Generic name | Stimulator, bone growth, non-invasive |
| Applicant | Djo, LLC |
| Product code | LOF |
| Received date | Jan 19, 2016 |
| Decision date | Feb 18, 2016 |
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: