This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the rh-2. The rha 2 is indicated 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. Rha 3 is indicated 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. Rha 4 is indicated 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.
| Device | RHA 2, RHA 3, RHA 4 |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | TEOXANE S.A. |
| Date Received | 2017-01-17 |
| Decision Date | 2017-10-19 |
| Notice Date | 2017-10-23 |
| PMA | P170002 |
| Supplement | S |
| Product Code | LMH |
| Docket Number | 17M-6232 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | TEOXANE S.A. rue De Lyon 105 geneva 1203 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170002 | Original Filing | |
| S025 | 2022-12-27 | 30-day Notice |
| S024 | ||
| S023 | ||
| S022 | ||
| S021 | 2022-03-17 | Real-time Process |
| S020 | 2022-01-31 | 30-day Notice |
| S019 | 2021-07-26 | Real-time Process |
| S018 | 2021-07-16 | 30-day Notice |
| S017 | 2021-04-26 | 30-day Notice |
| S016 | 2021-04-02 | 30-day Notice |
| S015 | 2021-03-29 | 30-day Notice |
| S014 | 2021-03-16 | Special (immediate Track) |
| S013 | 2021-02-17 | 30-day Notice |
| S012 | ||
| S011 | ||
| S010 | 2020-07-20 | 135 Review Track For 30-day Notice |
| S009 | 2020-02-14 | 30-day Notice |
| S008 | 2020-02-13 | 30-day Notice |
| S007 | 2019-11-13 | 30-day Notice |
| S006 | ||
| S005 | 2019-06-18 | Real-time Process |
| S004 | 2019-03-12 | 135 Review Track For 30-day Notice |
| S003 | 2019-03-12 | 30-day Notice |
| S002 | 2019-02-21 | 30-day Notice |
| S001 |