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.
| Device | RADIESSE® Injectable Implant |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050037 Supplement NumberS118 Date Received11/01/2022 Decision Date11/22/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-01 |
| Decision Date | 2022-11-22 |
| PMA | P050037 |
| Supplement | S118 |
| Product Code | LMH |
| 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 PMA NumberP050037 Supplement NumberS118 Date Received11/01/2022 Decision Date11/22/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement To Reduce The Frequency Of Air Particle Sampling From The Current Three (3) Times Per Month To One (1) Time Per Month In The Merz Site 125 Cleanroom. |
| 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 |