Approval for restylane refyne is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in patients over the age of 21. Restylane defyne is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe, deep facial wrinkles and folds (such as nasolabial folds) in patients over the age of 21.
| Device | Restylane Refyne, Restylane Defyne |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Q-Med AB |
| Date Received | 2014-12-11 |
| Decision Date | 2016-12-09 |
| Notice Date | 2016-12-14 |
| PMA | P140029 |
| Supplement | S |
| Product Code | LMH |
| Docket Number | 16M-4344 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Q-Med AB seminariegatan 21 uppsala S-752-7522 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
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