PMA supplement
P170002 S053: RHA® Redensity™ Mepi (also called RHA®1 Mepi), RHA®2 Mepi, RHA®3 Mepi, RHA® Dynamic Volume (formerly called RHA®4 Mepi)
FDA PMA supplement · 135 Review Track For 30-Day Notice · Teoxane S.A.
Key facts
| Original PMA | P170002 |
|---|---|
| Supplement number | S053 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | RHA® Redensity™ Mepi (also called RHA®1 Mepi), RHA®2 Mepi, RHA®3 Mepi, RHA® Dynamic Volume (formerly called RHA®4 Mepi) |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Teoxane S.A. |
| Product code | LMH |
| Received date | Jan 30, 2026 |
| Decision date | Mar 31, 2026 |
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: