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 2, RHA 3, RHA 4 dermal fillers |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | TEOXANE S.A.rue De Lyon 105geneva 1203 PMA NumberP170002 Supplement NumberS020 Date Received01/31/2022 Decision Date02/24/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-01-31 |
| Decision Date | 2022-02-24 |
| PMA | P170002 |
| Supplement | S020 |
| 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 PMA NumberP170002 Supplement NumberS020 Date Received01/31/2022 Decision Date02/24/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement Removal Of In-process Control (IPC) Tests For PH At Dialysis And Rheology At Filling During The Manufacturing Of RHA 2, RHA 3, And RHA 4 |
| 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 |