PMA supplement
P170002 S035: RHA® Redensity™, RHA® Redensity™ Mepi, RHA®2, RHA®2 Mepi, RHA®3, RHA®3 Mepi, RHA®4, RHA®4 Mepi
FDA PMA supplement · 135 Review Track For 30-Day Notice · Teoxane S.A.
Key facts
| Original PMA | P170002 |
|---|---|
| Supplement number | S035 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | RHA® Redensity™, RHA® Redensity™ Mepi, RHA®2, RHA®2 Mepi, RHA®3, RHA®3 Mepi, RHA®4, RHA®4 Mepi |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Teoxane S.A. |
| Product code | LMH |
| Received date | Dec 11, 2023 |
| Decision date | Jun 27, 2024 |
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: