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 modification to the formulation, syringe material, specifications, manufacturing process and labeling to support the addition of the lidocaine and improve manufacturing efficacy. The device as modified will be marketed under the trade name,radiesse® (+) and is indicated for sub-dermal implantation the correction of moderate to severe facial folds and wrinkles, including nasolabial folds.
| Device | RADIESSE (+) LIDOCAINE DERMAL FILTER |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | MERZ NORTH AMERICA, INC |
| Date Received | 2014-04-09 |
| Decision Date | 2015-01-30 |
| PMA | P050052 |
| Supplement | S052 |
| Product Code | LMH |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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 | MERZ NORTH AMERICA, INC 4133 Courtney Road suite 10 franksville, WI 53126 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050052 | Original Filing | |
| S142 | 2022-12-15 | 30-day Notice |
| S141 | ||
| S140 | 2022-11-01 | 30-day Notice |
| S139 | 2022-11-01 | 30-day Notice |
| S138 | ||
| S137 | ||
| S136 | 2022-04-12 | 135 Review Track For 30-day Notice |
| S135 | 2022-04-08 | 30-day Notice |
| S134 | 2022-01-06 | 30-day Notice |
| S133 | ||
| S132 | 2021-09-21 | Special (immediate Track) |
| S131 | 2021-02-05 | 135 Review Track For 30-day Notice |
| S130 | 2020-12-23 | 135 Review Track For 30-day Notice |
| S129 | ||
| S128 | ||
| S127 | 2020-09-25 | 30-day Notice |
| S126 | 2020-09-18 | 30-day Notice |
| S125 | 2020-09-18 | 30-day Notice |
| S124 | 2020-06-30 | 30-day Notice |
| S123 | ||
| S122 | 2020-04-21 | 30-day Notice |
| S121 | 2020-04-03 | 30-day Notice |
| S120 | ||
| S119 | 2019-12-18 | Normal 180 Day Track |
| S118 | 2019-11-26 | 30-day Notice |
| S117 | ||
| S116 | ||
| S115 | 2019-05-16 | 135 Review Track For 30-day Notice |
| S114 | 2019-05-10 | 30-day Notice |
| S113 | 2019-05-09 | 30-day Notice |
| S112 | 2019-05-07 | 30-day Notice |
| S111 | 2019-04-19 | 30-day Notice |
| S110 | 2018-10-15 | Normal 180 Day Track No User Fee |
| S109 | 2018-06-08 | 30-day Notice |
| S108 | 2018-06-08 | 30-day Notice |
| S107 | ||
| S106 | 2018-06-06 | 30-day Notice |
| S105 | 2018-04-02 | 135 Review Track For 30-day Notice |
| S104 | 2018-03-26 | 30-day Notice |
| S103 | ||
| S102 | 2018-01-16 | 30-day Notice |
| S101 | ||
| S100 | 2017-10-24 | 30-day Notice |
| S099 | 2017-10-19 | 30-day Notice |
| S098 | 2017-10-12 | Normal 180 Day Track No User Fee |
| S097 | 2017-07-31 | 30-day Notice |
| S096 | 2017-07-17 | Normal 180 Day Track No User Fee |
| S095 | 2017-06-06 | 30-day Notice |
| S094 | 2017-06-01 | 30-day Notice |
| S093 | 2017-04-07 | 30-day Notice |
| S092 | 2017-04-03 | 135 Review Track For 30-day Notice |
| S091 | 2017-01-18 | Normal 180 Day Track No User Fee |
| S090 | 2017-01-18 | Normal 180 Day Track No User Fee |
| S089 | 2016-12-23 | 30-day Notice |
| S088 | 2016-12-06 | 135 Review Track For 30-day Notice |
| S087 | 2016-07-22 | 30-day Notice |
| S086 | 2016-06-13 | 135 Review Track For 30-day Notice |
| S085 | 2016-05-31 | 30-day Notice |
| S084 | 2016-05-31 | 135 Review Track For 30-day Notice |
| S083 | 2016-05-26 | 30-day Notice |
| S082 | 2015-12-22 | 135 Review Track For 30-day Notice |
| S081 | 2015-12-11 | Normal 180 Day Track No User Fee |
| S080 | 2015-12-11 | 135 Review Track For 30-day Notice |
| S079 | 2015-12-07 | 135 Review Track For 30-day Notice |
| S078 | 2015-12-07 | Real-time Process |
| S077 | 2015-12-04 | 135 Review Track For 30-day Notice |
| S076 | 2015-12-02 | 135 Review Track For 30-day Notice |
| S075 | 2015-12-01 | 30-day Notice |
| S074 | 2015-10-20 | Special (immediate Track) |
| S073 | 2015-09-25 | 135 Review Track For 30-day Notice |
| S072 | 2015-09-04 | 30-day Notice |
| S071 | 2015-07-13 | Special (immediate Track) |
| S070 | 2015-07-02 | Normal 180 Day Track No User Fee |
| S069 | 2015-07-02 | Normal 180 Day Track No User Fee |
| S068 | 2015-06-26 | 30-day Notice |
| S067 | 2015-06-09 | 30-day Notice |
| S066 | 2015-05-06 | 30-day Notice |
| S065 | 2015-05-01 | 135 Review Track For 30-day Notice |
| S064 | 2015-04-09 | 30-day Notice |
| S063 | 2015-04-02 | 30-day Notice |
| S062 | 2015-03-27 | 135 Review Track For 30-day Notice |
| S061 | 2015-03-09 | 30-day Notice |
| S060 | 2015-03-04 | 30-day Notice |
| S059 | 2014-08-04 | 30-day Notice |
| S058 | 2014-07-28 | 30-day Notice |
| S057 | 2014-07-23 | 30-day Notice |
| S056 | 2014-07-23 | 30-day Notice |
| S055 | 2014-06-13 | 135 Review Track For 30-day Notice |
| S054 | 2014-05-23 | 30-day Notice |
| S053 | 2014-04-11 | 30-day Notice |
| S052 | 2014-04-09 | Normal 180 Day Track |
| S051 | 2014-02-21 | 30-day Notice |
| S050 | 2014-01-09 | 135 Review Track For 30-day Notice |
| S049 | 2013-12-02 | Panel Track |
| S048 | 2013-11-22 | 30-day Notice |
| S047 | 2013-11-13 | 30-day Notice |
| S046 | 2013-10-31 | 30-day Notice |
| S045 | 2013-10-17 | 135 Review Track For 30-day Notice |
| S044 | 2013-09-25 | 30-day Notice |
| S043 | 2013-08-21 | 30-day Notice |
| S042 | 2013-08-20 | 30-day Notice |
| S041 | 2013-06-20 | 30-day Notice |
| S040 | 2013-05-08 | 30-day Notice |
| S039 | 2013-03-25 | 30-day Notice |
| S038 | 2013-01-31 | 30-day Notice |
| S037 | 2012-09-20 | 30-day Notice |
| S036 | 2012-07-20 | Real-time Process |
| S035 | 2012-03-06 | 135 Review Track For 30-day Notice |
| S034 | 2011-12-22 | 135 Review Track For 30-day Notice |
| S033 | 2011-06-08 | 30-day Notice |
| S032 | 2011-06-02 | Real-time Process |
| S031 | 2011-03-30 | Normal 180 Day Track No User Fee |
| S030 | 2011-01-12 | Normal 180 Day Track No User Fee |
| S029 | 2011-01-11 | Normal 180 Day Track No User Fee |
| S028 | 2010-11-22 | 30-day Notice |
| S027 | 2010-07-02 | Normal 180 Day Track |
| S026 | 2010-05-17 | 135 Review Track For 30-day Notice |
| S025 | 2010-02-12 | 30-day Notice |
| S024 | 2009-10-06 | 30-day Notice |
| S023 | ||
| S022 | 2009-02-06 | 30-day Notice |
| S021 | 2009-02-05 | 30-day Notice |
| S020 | 2009-01-29 | Real-time Process |
| S019 | 2009-01-14 | Normal 180 Day Track |
| S018 | 2008-12-09 | Real-time Process |
| S017 | 2008-12-08 | 30-day Notice |
| S016 | 2008-11-06 | 30-day Notice |
| S015 | 2008-10-21 | 30-day Notice |
| S014 | 2008-10-16 | 30-day Notice |
| S013 | 2008-10-01 | 30-day Notice |
| S012 | 2008-08-04 | 30-day Notice |
| S011 | ||
| S010 | 2008-06-30 | 30-day Notice |
| S009 | 2008-06-11 | 30-day Notice |
| S008 | ||
| S007 | 2008-01-28 | 30-day Notice |
| S006 | 2007-12-26 | Real-time Process |
| S005 | 2007-11-20 | 135 Review Track For 30-day Notice |
| S004 | 2007-05-18 | Normal 180 Day Track |
| S003 | 2007-05-16 | 30-day Notice |
| S002 | 2007-04-18 | 30-day Notice |
| S001 |