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.
Implementation of the international council for harmonization (ich) elemental impurities guideline and change in the test method and specification to assay aluminum by the raw material supplier for the hyaluronic acid
| Device | RHA 2, RHA 3, RHA 4 dermal fillers |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | TEOXANE S.A. |
| Date Received | 2019-03-12 |
| Decision Date | 2019-11-01 |
| PMA | P170002 |
| Supplement | S004 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | TEOXANE S.A. rue De Lyon 105 geneva 1203 |
| 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 |