PMA supplement
P850022 S013: BIOLECTRON ORTHOPAK BONE GROWTH STIMULAOR & BIOLECTRON SPINALPAK FUSION STIMULATOR
FDA PMA supplement · Normal 180 Day Track · Ahp Eos Buyer, Inc.
Key facts
| Original PMA | P850022 |
|---|---|
| Supplement number | S013 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Express GMP Supplement |
| Trade name | BIOLECTRON ORTHOPAK BONE GROWTH STIMULAOR & BIOLECTRON SPINALPAK FUSION STIMULATOR |
| Generic name | Stimulator, bone growth, non-invasive |
| Applicant | Ahp Eos Buyer, Inc. |
| Product code | LOF |
| Received date | Jun 11, 2001 |
| Decision date | Oct 10, 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: