PMA supplement
P170002 S026: RHA® Redensity Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi
FDA PMA supplement · Panel Track · Teoxane S.A.
Key facts
| Original PMA | P170002 |
|---|---|
| Supplement number | S026 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | RHA® Redensity Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Teoxane S.A. |
| Product code | LMH |
| Received date | Feb 15, 2023 |
| Decision date | Oct 13, 2023 |
| Docket number | 23M-5214 |
| Notice date | Nov 28, 2023 |
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: