Belotero Balance (+) Lidocaine

FDA Premarket Approval P090016 S049

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

DeviceBelotero Balance (+) Lidocaine
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantMERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP090016 Supplement NumberS049 Date Received07/21/2022 Decision Date10/26/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-07-21
Decision Date2022-10-26
PMAP090016
SupplementS049
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductYes
Applicant AddressMERZ NORTH AMERICA, INC
4133 Courtney Road
suite 10
franksville, WI 53126 PMA NumberP090016 Supplement NumberS049 Date Received07/21/2022 Decision Date10/26/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductYes Approval Order Statement  
Approval To Increase The Tolerance Range For The Lidocaine Hydrochloride Specification From 3.00 ± 5% Mg/mL (2.85-3.15 Mg/mL) To 3.0 ± 10% Mg/mL (2.7 - 3.3 Mg/mL).

Supplemental Filings

Supplement NumberDateSupplement Type
P090016Original 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 IDPMASupp
07640123791121 P090016 000
07640123791213 P090016 000

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