PMA supplement
P800035 S008: AUGMEN(TM) AKA SYNTHOGRAFT(TM) LG
FDA PMA supplement · Curasan AG
Key facts
| Original PMA | P800035 |
|---|---|
| Supplement number | S008 |
| Trade name | AUGMEN(TM) AKA SYNTHOGRAFT(TM) LG |
| Generic name | Implant, endosseous, root-form |
| Applicant | Curasan AG |
| Product code | DZE |
| Received date | Oct 11, 1983 |
| Decision date | Nov 10, 1983 |
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: