RADIESSE® Injectable Implant

FDA Premarket Approval P050037 S114

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
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantMERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050037 Supplement NumberS114 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
PMAP050037
SupplementS114
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 NumberP050037 Supplement NumberS114 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
P050037Original Filing
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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