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 restylane lyft with lidocaine for expanding the indications to include injection into the subcutaneous plane in the dorsal hand to correct volume deficit in patients over the age of 21
| Device | Restylane Lyft with Lidocaine |
| Classification Name | Implant, Dermal, For Aesthetic Use In The Hands |
| Generic Name | Implant, Dermal, For Aesthetic Use In The Hands |
| Applicant | Q-Med AB |
| Date Received | 2017-08-29 |
| Decision Date | 2018-05-18 |
| Notice Date | 2018-05-22 |
| PMA | P040024 |
| Supplement | S099 |
| Product Code | PKY |
| Docket Number | 18M-1970 |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Q-Med AB seminariegatan 21 uppsala SE-75-752- |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| 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 |