Radiesse Injectable Implant

Implant, Dermal, For Aesthetic Use

FDA Premarket Approval P050037 S098

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

Approval for modifications to the manufacturing equipment for coaptite injectable implant, radiesse injectable implant, and radiesse (+) lidocaine dermal filler.

DeviceRadiesse Injectable Implant
Classification NameImplant, Dermal, For Aesthetic Use
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantMERZ NORTH AMERICA, INC
Date Received2019-05-16
Decision Date2019-11-06
PMAP050037
SupplementS098
Product CodeLMH
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MERZ NORTH AMERICA, INC 4133 Courtney Road suite 10 franksville, WI 53126

Supplemental Filings

Supplement NumberDateSupplement Type
P050037Original Filing
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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