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 | Restlyane® Refyne Injectable Gel |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Q-Med ABseminariegatan 21uppsala S-752-7522 PMA NumberP140029 Supplement NumberS047 Date Received11/21/2022 Decision Date12/23/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-11-21 |
| Decision Date | 2022-12-23 |
| PMA | P140029 |
| Supplement | S047 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Q-Med AB seminariegatan 21 uppsala S-752-7522 PMA NumberP140029 Supplement NumberS047 Date Received11/21/2022 Decision Date12/23/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductYes Approval Order Statement Approval For Revisions To The Clinician Labeling And Patient Labeling Of Restylane® Refyne Injectable Gel As A Result Of Postmarket Surveillance Data. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 03770034301059 | P140029 | 000 |
| 03770034301042 | P140029 | 000 |
| 03770034301028 | P140029 | 000 |
| 07331689115833 | P140029 | 032 |
| 07331689115826 | P140029 | 032 |
| 07331689116069 | P140029 | 033 |
| 07331689116052 | P140029 | 033 |
| 07331689121452 | P140029 | 051 |
| 07331689121445 | P140029 | 051 |