This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the restylane injectable gel. The device is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
| Device | RESTYLANE INJECTABLE GEL |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Q-Med AB |
| Date Received | 2004-05-10 |
| Decision Date | 2005-03-25 |
| Notice Date | 2005-04-12 |
| PMA | P040024 |
| Supplement | S |
| Product Code | LMH |
| Docket Number | 05M-0118 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Q-Med AB seminariegatan 21 uppsala SE-75-752- |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040024 | Original Filing | |
| S136 | 2022-11-21 | Special (immediate Track) |
| S135 | ||
| S134 | 2022-09-07 | 30-day Notice |
| S133 | ||
| S132 | ||
| S131 | 2022-04-04 | Real-time Process |
| S130 | 2021-11-17 | 30-day Notice |
| S129 | 2021-11-17 | 30-day Notice |
| S128 | 2021-11-15 | 30-day Notice |
| S127 | ||
| S126 | 2021-07-28 | 30-day Notice |
| S125 | ||
| S124 | ||
| S123 | ||
| S122 | ||
| S121 | 2020-10-07 | 30-day Notice |
| S120 | 2020-09-14 | 30-day Notice |
| S119 | ||
| S118 | 2020-01-28 | 30-day Notice |
| S117 | ||
| S116 | 2019-07-10 | Real-time Process |
| S115 | 2019-07-02 | Real-time Process |
| S114 | ||
| S113 | 2019-05-21 | 30-day Notice |
| S112 | ||
| S111 | 2019-05-20 | 30-day Notice |
| S110 | 2019-04-18 | 30-day Notice |
| S109 | ||
| S108 | ||
| S107 | 2019-01-31 | 30-day Notice |
| S106 | ||
| S105 | 2018-11-19 | 30-day Notice |
| S104 | ||
| S103 | 2018-11-01 | Normal 180 Day Track |
| S102 | 2018-07-06 | 30-day Notice |
| S101 | 2018-04-20 | Normal 180 Day Track |
| S100 | 2017-10-24 | 30-day Notice |
| S099 | 2017-08-29 | Panel Track |
| S098 | 2017-07-10 | 30-day Notice |
| S097 | 2017-07-03 | 30-day Notice |
| S096 | 2017-02-16 | Normal 180 Day Track |
| S095 | 2016-12-13 | 135 Review Track For 30-day Notice |
| S094 | 2016-11-01 | Special (immediate Track) |
| S093 | 2016-10-06 | 30-day Notice |
| S092 | 2016-08-29 | 135 Review Track For 30-day Notice |
| S091 | 2016-07-20 | 30-day Notice |
| S090 | 2016-01-22 | 135 Review Track For 30-day Notice |
| S089 | 2015-10-29 | Special (immediate Track) |
| S088 | 2015-10-29 | Special (immediate Track) |
| S087 | 2015-10-15 | 30-day Notice |
| S086 | 2015-09-18 | 135 Review Track For 30-day Notice |
| S085 | 2015-09-02 | 30-day Notice |
| S084 | 2015-09-02 | 30-day Notice |
| S083 | 2015-08-31 | Real-time Process |
| S082 | 2015-08-28 | Special (immediate Track) |
| S081 | 2015-08-18 | 30-day Notice |
| S080 | ||
| S079 | 2015-02-12 | Normal 180 Day Track |
| S078 | 2014-10-03 | 30-day Notice |
| S077 | 2014-07-09 | 30-day Notice |
| S076 | 2014-07-02 | 135 Review Track For 30-day Notice |
| S075 | 2014-06-05 | 30-day Notice |
| S074 | 2014-05-28 | 30-day Notice |
| S073 | 2014-05-01 | Panel Track |
| S072 | 2013-10-21 | Panel Track |
| S071 | 2013-09-26 | 30-day Notice |
| S070 | 2013-05-28 | Normal 180 Day Track |
| S069 | ||
| S068 | 2013-01-31 | 30-day Notice |
| S067 | ||
| S066 | 2012-12-11 | 30-day Notice |
| S065 | 2012-12-04 | Real-time Process |
| S064 | 2012-11-01 | 30-day Notice |
| S063 | ||
| S062 | 2012-07-13 | Real-time Process |
| S061 | 2012-07-10 | 30-day Notice |
| S060 | 2012-06-27 | 30-day Notice |
| S059 | 2012-04-25 | 30-day Notice |
| S058 | 2012-04-23 | 30-day Notice |
| S057 | ||
| S056 | 2012-01-10 | Panel Track |
| S055 | 2011-11-04 | 135 Review Track For 30-day Notice |
| S054 | 2011-07-21 | 30-day Notice |
| S053 | 2011-07-07 | Normal 180 Day Track No User Fee |
| S052 | 2011-01-28 | Normal 180 Day Track |
| S051 | 2010-12-01 | Panel Track |
| S050 | 2010-10-22 | 135 Review Track For 30-day Notice |
| S049 | 2010-07-13 | 30-day Notice |
| S048 | ||
| S047 | ||
| S046 | 2010-03-08 | 30-day Notice |
| S045 | 2009-11-25 | 135 Review Track For 30-day Notice |
| S044 | 2009-10-01 | 30-day Notice |
| S043 | 2009-07-16 | 30-day Notice |
| S042 | 2009-07-08 | 30-day Notice |
| S041 | 2009-06-10 | 30-day Notice |
| S040 | 2009-05-13 | 30-day Notice |
| S039 | 2009-04-16 | Normal 180 Day Track |
| S038 | 2009-03-25 | 30-day Notice |
| S037 | 2009-03-17 | 30-day Notice |
| S036 | 2009-03-11 | 30-day Notice |
| S035 | 2009-02-09 | 30-day Notice |
| S034 | 2009-02-02 | 30-day Notice |
| S033 | 2009-01-15 | 30-day Notice |
| S032 | 2008-12-31 | 30-day Notice |
| S031 | 2008-12-03 | 30-day Notice |
| S030 | 2008-11-26 | 30-day Notice |
| S029 | 2008-09-29 | 30-day Notice |
| S028 | 2008-09-22 | 30-day Notice |
| S027 | 2008-07-25 | 30-day Notice |
| S026 | 2008-06-27 | Special (immediate Track) |
| S025 | 2008-06-23 | 30-day Notice |
| S024 | 2008-06-17 | 30-day Notice |
| S023 | 2008-06-09 | Normal 180 Day Track |
| S022 | 2008-05-19 | Special (immediate Track) |
| S021 | 2008-04-07 | 30-day Notice |
| S020 | 2008-03-13 | 30-day Notice |
| S019 | 2008-03-10 | 30-day Notice |
| S018 | 2008-02-07 | 135 Review Track For 30-day Notice |
| S017 | 2008-01-11 | 30-day Notice |
| S016 | 2007-10-31 | 135 Review Track For 30-day Notice |
| S015 | 2007-10-30 | 135 Review Track For 30-day Notice |
| S014 | ||
| S013 | 2007-09-14 | 30-day Notice |
| S012 | 2007-08-21 | Normal 180 Day Track No User Fee |
| S011 | 2007-06-19 | 30-day Notice |
| S010 | 2007-06-12 | 30-day Notice |
| S009 | 2007-05-11 | 30-day Notice |
| S008 | 2007-05-09 | 30-day Notice |
| S007 | 2006-05-15 | 30-day Notice |
| S006 | 2006-03-28 | Panel Track |
| S005 | 2006-02-02 | Special (immediate Track) |
| S004 | 2006-01-09 | Special (immediate Track) |
| S003 | ||
| S002 | 2005-06-24 | Normal 180 Day Track No User Fee |
| S001 | 2005-06-16 | 30-day Notice |