RADIESSE INJECTABLE IMPLANT

Implant, Dermal, For Aesthetic Use

FDA Premarket Approval P050052

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for radiesse. This device is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.

• Device: RADIESSE INJECTABLE IMPLANT
• Classification Name: Implant, Dermal, For Aesthetic Use
• Generic Name: Implant, Dermal, For Aesthetic Use
• Applicant: MERZ NORTH AMERICA, INC
• Date Received: 2005-12-22
• Decision Date: 2006-12-22
• Notice Date: 2007-01-17
• PMA: P050052
• Supplement: S
• Product Code: LMH
• Docket Number: 07M-0007
• Advisory Committee: General & Plastic Surgery
• Expedited Review: No
• Combination Product: No
• Applicant Address: MERZ NORTH AMERICA, INC 4133 Courtney Road suite 10 franksville, WI 53126
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

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