RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler

FDA Premarket Approval P050052 S127

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

Permission for merz na to inspect incoming glycerin raw material in-house in alignment with the usp-nf glycerin monograph used in coaptite, radiesse, and radiesse (+) products

• Device: RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler
• Generic Name: Implant, Dermal, For Aesthetic Use
• Applicant: MERZ NORTH AMERICA, INC
• Date Received: 2020-09-25
• Decision Date: 2020-10-23
• PMA: P050052
• Supplement: S127
• Product Code: LMH
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: MERZ NORTH AMERICA, INC 4133 Courtney Road suite 10 franksville, WI 53126

Supplemental Filings

Supplement Number	Date	Supplement Type
P050052		Original Filing
S142	2022-12-15	30-day Notice
S141
S140	2022-11-01	30-day Notice
S139	2022-11-01	30-day Notice
S138
S137
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

NIH GUDID Devices

Device ID	PMA	Supp
03770034301097	P050052	000