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

FDA Premarket Approval P050052 S135

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, including RADIESSE® Hands, RADIESSE® (+) Lidocaine, and RADIESSE® (+) Jawline
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantMERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050052 Supplement NumberS135 Date Received04/08/2022 Decision Date05/05/2022 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 Received2022-04-08
Decision Date2022-05-05
PMAP050052
SupplementS135
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-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 NumberS135 Date Received04/08/2022 Decision Date05/05/2022 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 ProductYes Approval Order Statement  
change In The Number Of Replicates Used During The Out Of Specification Of Endotoxin Testing.

Supplemental Filings

Supplement NumberDateSupplement Type
P050052Original Filing
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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