To change the sterilization validation approach to the overkill method/full cycle approach defined in iso 17665-1:2006 annex d4
| Device | Restylane Refyne, Restylane Defyne, and Restylane Kysse Injectable Gels |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Q-Med AB |
| Date Received | 2020-07-29 |
| Decision Date | 2020-08-28 |
| PMA | P140029 |
| Supplement | S028 |
| 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 | Q-Med AB seminariegatan 21 uppsala S-752-7522 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P140029 | | Original Filing |
| S047 |
2022-11-21 |
Special (immediate Track) |
| S046 |
2022-09-07 |
30-day Notice |
| S045 | | |
| S044 |
2021-11-15 |
30-day Notice |
| S043 |
2021-11-05 |
30-day Notice |
| S042 |
2021-09-27 |
30-day Notice |
| S041 | | |
| S040 |
2021-06-02 |
135 Review Track For 30-day Notice |
| S039 | | |
| S038 |
2021-03-16 |
30-day Notice |
| S037 |
2021-03-15 |
30-day Notice |
| S036 |
2021-02-01 |
30-day Notice |
| S035 | | |
| S034 |
2020-10-07 |
30-day Notice |
| S033 | | |
| S032 | | |
| S031 | | |
| S030 |
2020-09-14 |
30-day Notice |
| S029 | | |
| S028 |
2020-07-29 |
30-day Notice |
| S027 | | |
| S026 |
2020-06-04 |
30-day Notice |
| S025 |
2020-04-21 |
Special (immediate Track) |
| S024 |
2020-02-18 |
30-day Notice |
| S023 |
2020-01-21 |
30-day Notice |
| S022 | | |
| S021 |
2019-09-03 |
Panel Track |
| S020 |
2019-08-15 |
30-day Notice |
| S019 | | |
| S018 | | |
| S017 |
2019-05-17 |
Real-time Process |
| S016 |
2019-02-14 |
30-day Notice |
| S015 |
2018-10-22 |
30-day Notice |
| S014 |
2018-09-19 |
30-day Notice |
| S013 |
2018-08-23 |
30-day Notice |
| S012 |
2018-06-01 |
30-day Notice |
| S011 |
2018-05-25 |
30-day Notice |
| S010 |
2018-05-23 |
30-day Notice |
| S009 |
2018-05-18 |
30-day Notice |
| S008 |
2018-05-16 |
30-day Notice |
| S007 |
2018-04-26 |
Real-time Process |
| S006 |
2017-12-18 |
135 Review Track For 30-day Notice |
| S005 | | |
| S004 |
2017-06-14 |
Normal 180 Day Track No User Fee |
| S003 |
2017-06-08 |
30-day Notice |
| S002 | | |
| S001 |
2017-01-11 |
135 Review Track For 30-day Notice |
NIH GUDID Devices