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 the addition of the following changes to the product specifications for the phosphate buffer concentrate: 1) to narrow the specification limit for the concentration of the buffering ions in the phosphate buffer to 23. 4 ¿ 28. 4 mg/ml for the potassium dihydrogen phosphate content and to 131-157 mg/ml for the disodium hydrogen phosphate content; 2) to add the bacterial endotoxin test to the phosphate buffer concentrate specification; and 3) to add the ph test to the phosphate buffer specification.
| Device | RESTYLANE INJECTABLE GEL |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Q-Med AB |
| Date Received | 2008-06-27 |
| Decision Date | 2008-07-15 |
| PMA | P040024 |
| Supplement | S026 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Special (immediate Track) |
| 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 |