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.
To declare the change of analytical laboratory in charge of the assay of sodium hyaluronate (naha) content in the finished products at the release step for rha2, rha3, and rha4
| Device | RHA 2, RHA 3, RHA 4 |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | TEOXANE S.A. |
| Date Received | 2021-02-17 |
| Decision Date | 2021-03-19 |
| PMA | P170002 |
| Supplement | S013 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 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 |