BELOTERO BALANCE

Implant, Dermal, For Aesthetic Use

FDA Premarket Approval P090016

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 belotero balance. This device is indicated for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds such as nasolabial folds.

• Device: BELOTERO BALANCE
• Classification Name: Implant, Dermal, For Aesthetic Use
• Generic Name: Implant, Dermal, For Aesthetic Use
• Applicant: MERZ NORTH AMERICA, INC
• Date Received: 2009-07-23
• Decision Date: 2011-11-14
• Notice Date: 2011-11-22
• PMA: P090016
• Supplement: S
• Product Code: LMH
• Docket Number: 11M-0832
• 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
P090016		Original Filing
S049	2022-07-21	Normal 180 Day Track
S048	2022-04-05	30-day Notice
S047
S046	2021-09-15	30-day Notice
S045
S044
S043	2020-09-29	30-day Notice
S042
S041
S040
S039
S038	2020-01-08	30-day Notice
S037
S036	2019-11-06	Real-time Process
S035	2019-08-23	135 Review Track For 30-day Notice
S034
S033	2019-07-02	30-day Notice
S032	2019-05-23	30-day Notice
S031	2018-09-25	30-day Notice
S030	2018-06-25	30-day Notice
S029
S028	2018-04-20	Normal 180 Day Track
S027	2018-03-05	30-day Notice
S026	2018-03-05	30-day Notice
S025	2017-10-12	Normal 180 Day Track No User Fee
S024
S023	2017-03-21	30-day Notice
S022	2016-11-23	30-day Notice
S021
S020	2016-03-17	30-day Notice
S019	2015-12-01	135 Review Track For 30-day Notice
S018	2015-11-04	Special (immediate Track)
S017	2015-06-05	Special (immediate Track)
S016	2015-06-02	Real-time Process
S015	2015-04-02	30-day Notice
S014	2015-02-19	30-day Notice
S013	2014-11-28	135 Review Track For 30-day Notice
S012	2014-08-07	30-day Notice
S011	2014-08-06	30-day Notice
S010	2014-08-05	30-day Notice
S009	2014-04-11	Normal 180 Day Track No User Fee
S008	2014-01-14	Real-time Process
S007	2013-06-19	30-day Notice
S006	2013-02-21	30-day Notice
S005	2013-01-28	30-day Notice
S004	2012-10-25	Normal 180 Day Track No User Fee
S003	2012-10-10	Normal 180 Day Track No User Fee
S002	2012-07-02	Real-time Process
S001	2011-12-14	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
07640123791121	P090016	000
07640123791213	P090016	000
07640123791152	P090016	000
M2138700M05	P090016	000