Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler

FDA Premarket Approval P090016 S048

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 Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantMERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP090016 Supplement NumberS048 Date Received04/05/2022 Decision Date05/05/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-05
Decision Date2022-05-05
PMAP090016
SupplementS048
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressMERZ NORTH AMERICA, INC
4133 Courtney Road
suite 10
franksville, WI 53126 PMA NumberP090016 Supplement NumberS048 Date Received04/05/2022 Decision Date05/05/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
to Modify The Depyrogenation Cycle For The Equipment Used In The Manufacturing Of Belotero Balance Dermal Filler And Belotero Balance With Lidocaine Dermal Filler

Supplemental Filings

Supplement NumberDateSupplement Type
P090016Original Filing
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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