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.
Approval for an extension to the expiration date of the lidocaine hydrochloride raw material from 12 months to 24 months.
| Device | RESTYLANE INJECTABLE GEL |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Q-Med AB |
| Date Received | 2011-01-28 |
| Decision Date | 2011-07-18 |
| PMA | P040024 |
| Supplement | S052 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Q-Med AB seminariegatan 21 uppsala SE-75-752- |
| 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 |