RADIESSE 1.3CC AND 0.3CC

Implant, Dermal, For Aesthetic Use

FDA Premarket Approval P050037

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.

Pre-market Approval Supplement Details

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.

DeviceRADIESSE 1.3CC AND 0.3CC
Classification NameImplant, Dermal, For Aesthetic Use
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantMERZ NORTH AMERICA, INC
Date Received2005-09-29
Decision Date2006-12-22
Notice Date2007-01-17
PMAP050037
SupplementS
Product CodeLMH
Docket Number07M-0006
Advisory CommitteeGeneral & Plastic Surgery
Expedited ReviewNo
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

Supplemental Filings

Supplement NumberDateSupplement Type
P050037Original 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

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