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.
Evaluation of the in-house manufacturing source of calcium hydroxylapatite particles as an additional supplier for this component of radiesse.
| Device | RADIESSE INJECTABLE IMPLANT |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | MERZ NORTH AMERICA, INC |
| Date Received | 2010-11-22 |
| Decision Date | 2010-12-22 |
| PMA | P050052 |
| Supplement | S028 |
| 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 | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| 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 |