RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline

FDA Premarket Approval P050052 S136

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.

Pre-market Approval Supplement Details

DeviceRADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantMERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050052 Supplement NumberS136 Date Received04/12/2022 Decision Date09/02/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-12
Decision Date2022-09-02
PMAP050052
SupplementS136
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressMERZ NORTH AMERICA, INC
4133 Courtney Road
suite 10
franksville, WI 53126 PMA NumberP050052 Supplement NumberS136 Date Received04/12/2022 Decision Date09/02/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
Approval For The Implementation Of A Different Blender Into The Calcium Hydroxylapatite (CaHA) Particle Manufacturing Process.

Supplemental Filings

Supplement NumberDateSupplement Type
P050052Original Filing
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

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