PMA supplement
P170002 S012: RHA® Redensity™
FDA PMA supplement · Panel Track · Teoxane S.A.
Key facts
| Original PMA | P170002 |
|---|---|
| Supplement number | S012 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | RHA® Redensity™ |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Teoxane S.A. |
| Product code | LMH |
| Received date | Jan 8, 2021 |
| Decision date | Dec 22, 2021 |
| Docket number | 22M-0071 |
| Notice date | Jan 4, 2022 |
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: