| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
| |
| Device | RHA® Redensity Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi |
|---|
| Generic Name | Implant, dermal, for aesthetic use |
|---|
| Applicant | TEOXANE S.A.
Les Charmilles
Rue de Lyon 105
Geneva 1203 |
|---|
| PMA Number | P170002 |
|---|
| Supplement Number | S026 |
|---|
| Date Received | 02/15/2023 |
|---|
| Decision Date | 10/13/2023 |
|---|
| Product Code |
LMH |
| Docket Number | 23M-5214 |
|---|
| Notice Date | 11/28/2023 |
|---|
| Advisory Committee |
General & Plastic Surgery |
|---|
| Supplement Type | Panel Track |
|---|
| Supplement Reason | Change Design/Components/Specifications/Material |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | Yes |
|---|
Approval Order Statement
Approval of RHA® Redensity Mepi injection into the dermis and superficial dermis of the face, for the correction of moderate to severe dynamic perioral rhytids, in adults aged 22 years or older. Approval of RHA®2 Mepi, RHA@3 Mepi for injection into the mid-to-deep dermis for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLF), in adults aged 22 years or older. Approval of RHA@4 Mepi for injection into the deep dermis to superficial subcutaneous tissue for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLF), in adults aged 22 years or older. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
|---|
| Labeling | Labeling
Labeling Part 2 |
|---|
| Post-Approval Study | Show Report Schedule and Study Progress |
|---|
|
|
