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 a change in the composition of the biological indicator used for qualification and requalification of the steam sterilization procedure.
| Device | RESTYLANE INJECTABLE GEL |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Q-Med AB |
| Date Received | 2010-10-22 |
| Decision Date | 2011-07-01 |
| PMA | P040024 |
| Supplement | S050 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Q-Med AB seminariegatan 21 uppsala SE-75-752- |
| 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 |