This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for radiesse. This device is indicated for subdermal implantation for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.
| Device | RADIESSE 1.3CC AND 0.3CC |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | MERZ NORTH AMERICA, INC |
| Date Received | 2005-09-29 |
| Decision Date | 2006-12-22 |
| Notice Date | 2007-01-17 |
| PMA | P050037 |
| Supplement | S |
| Product Code | LMH |
| Docket Number | 07M-0006 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MERZ NORTH AMERICA, INC 4133 Courtney Road suite 10 franksville, WI 53126 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050037 | Original Filing | |
| S121 | 2022-12-15 | 30-day Notice |
| S120 | 2022-12-09 | 30-day Notice |
| S119 | 2022-11-01 | 30-day Notice |
| S118 | 2022-11-01 | 30-day Notice |
| S117 | ||
| S116 | ||
| S115 | 2022-04-12 | 135 Review Track For 30-day Notice |
| S114 | 2022-04-08 | 30-day Notice |
| S113 | 2022-01-06 | 30-day Notice |
| S112 | 2021-09-21 | Special (immediate Track) |
| S111 | 2020-12-23 | 135 Review Track For 30-day Notice |
| S110 | ||
| S109 | 2020-09-25 | 30-day Notice |
| S108 | 2020-09-18 | 30-day Notice |
| S107 | 2020-09-18 | 30-day Notice |
| S106 | 2020-06-30 | 30-day Notice |
| S105 | ||
| S104 | 2020-04-21 | 30-day Notice |
| S103 | 2020-04-03 | 30-day Notice |
| S102 | ||
| S101 | 2019-11-26 | 30-day Notice |
| S100 | ||
| S099 | ||
| S098 | 2019-05-16 | 135 Review Track For 30-day Notice |
| S097 | 2019-05-10 | 30-day Notice |
| S096 | 2019-05-09 | 30-day Notice |
| S095 | 2019-05-07 | 30-day Notice |
| S094 | 2019-04-19 | 30-day Notice |
| S093 | 2018-06-08 | 30-day Notice |
| S092 | 2018-06-08 | 30-day Notice |
| S091 | ||
| S090 | 2018-06-06 | 30-day Notice |
| S089 | 2018-04-02 | 135 Review Track For 30-day Notice |
| S088 | 2018-03-26 | 30-day Notice |
| S087 | ||
| S086 | 2018-01-16 | 30-day Notice |
| S085 | ||
| S084 | 2017-10-24 | 30-day Notice |
| S083 | 2017-10-19 | 30-day Notice |
| S082 | 2017-10-12 | Normal 180 Day Track No User Fee |
| S081 | 2017-06-06 | 30-day Notice |
| S080 | 2017-06-01 | 30-day Notice |
| S079 | 2017-04-07 | 30-day Notice |
| S078 | 2017-04-03 | 135 Review Track For 30-day Notice |
| S077 | 2016-12-23 | 30-day Notice |
| S076 | 2016-12-06 | 135 Review Track For 30-day Notice |
| S075 | 2016-07-22 | 30-day Notice |
| S074 | 2016-06-13 | 135 Review Track For 30-day Notice |
| S073 | 2016-05-31 | 30-day Notice |
| S072 | 2016-05-31 | 135 Review Track For 30-day Notice |
| S071 | 2016-05-26 | 30-day Notice |
| S070 | 2015-12-22 | 135 Review Track For 30-day Notice |
| S069 | 2015-12-11 | 135 Review Track For 30-day Notice |
| S068 | 2015-12-07 | 135 Review Track For 30-day Notice |
| S067 | 2015-12-07 | Real-time Process |
| S066 | 2015-12-04 | 135 Review Track For 30-day Notice |
| S065 | 2015-12-02 | 135 Review Track For 30-day Notice |
| S064 | 2015-12-01 | 30-day Notice |
| S063 | 2015-10-20 | Special (immediate Track) |
| S062 | 2015-09-04 | 30-day Notice |
| S061 | 2015-07-13 | Special (immediate Track) |
| S060 | 2015-06-26 | 30-day Notice |
| S059 | 2015-05-01 | 135 Review Track For 30-day Notice |
| S058 | 2015-04-09 | 30-day Notice |
| S057 | 2015-04-02 | 30-day Notice |
| S056 | 2015-03-27 | 135 Review Track For 30-day Notice |
| S055 | 2015-03-09 | 30-day Notice |
| S054 | 2014-08-04 | 30-day Notice |
| S053 | 2014-07-28 | 30-day Notice |
| S052 | 2014-07-23 | 30-day Notice |
| S051 | 2014-07-23 | 30-day Notice |
| S050 | 2014-06-13 | 135 Review Track For 30-day Notice |
| S049 | 2014-05-23 | 30-day Notice |
| S048 | 2014-04-11 | 30-day Notice |
| S047 | 2014-02-21 | 30-day Notice |
| S046 | 2014-01-09 | 135 Review Track For 30-day Notice |
| S045 | 2013-11-22 | 30-day Notice |
| S044 | 2013-11-13 | 30-day Notice |
| S043 | 2013-10-31 | 30-day Notice |
| S042 | 2013-10-17 | 135 Review Track For 30-day Notice |
| S041 | 2013-09-25 | 30-day Notice |
| S040 | 2013-08-21 | 30-day Notice |
| S039 | 2013-08-20 | 30-day Notice |
| S038 | 2013-06-20 | 30-day Notice |
| S037 | 2013-05-08 | 30-day Notice |
| S036 | 2013-03-25 | 30-day Notice |
| S035 | 2013-01-31 | 30-day Notice |
| S034 | 2012-09-20 | 30-day Notice |
| S033 | 2012-07-20 | Real-time Process |
| S032 | 2012-03-06 | 135 Review Track For 30-day Notice |
| S031 | 2011-12-22 | 135 Review Track For 30-day Notice |
| S030 | 2011-06-08 | 30-day Notice |
| S029 | 2011-06-02 | Real-time Process |
| S028 | 2011-03-30 | Normal 180 Day Track No User Fee |
| S027 | 2011-01-12 | Normal 180 Day Track No User Fee |
| S026 | 2011-01-11 | Normal 180 Day Track No User Fee |
| S025 | 2010-11-22 | 30-day Notice |
| S024 | 2010-07-02 | Normal 180 Day Track |
| S023 | ||
| S022 | 2010-02-12 | 30-day Notice |
| S021 | 2009-10-06 | 30-day Notice |
| S020 | 2009-02-06 | 30-day Notice |
| S019 | 2009-02-05 | 30-day Notice |
| S018 | 2009-01-29 | Real-time Process |
| S017 | 2008-12-09 | Real-time Process |
| S016 | 2008-12-08 | 30-day Notice |
| S015 | 2008-11-06 | 30-day Notice |
| S014 | 2008-10-21 | 30-day Notice |
| S013 | 2008-10-16 | 30-day Notice |
| S012 | 2008-10-01 | 30-day Notice |
| S011 | 2008-08-04 | 30-day Notice |
| S010 | ||
| S009 | 2008-06-30 | 30-day Notice |
| S008 | 2008-06-11 | 30-day Notice |
| S007 | ||
| S006 | 2008-01-28 | 30-day Notice |
| S005 | 2007-12-26 | Real-time Process |
| S004 | 2007-11-20 | 135 Review Track For 30-day Notice |
| S003 | 2007-05-18 | Normal 180 Day Track |
| S002 | 2007-05-16 | 30-day Notice |
| S001 | 2007-04-18 | 30-day Notice |