Belotero Balance

FDA Premarket Approval P090016 S043

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

The addition of a camera system to the carton packaging line and the change to the tamper evident seal of the carton packaging. Please be advised that the changes proposed and accepted in p090016/s043 are not to be implemented until after inspections for site-change supplement, p090016/s034 is completed, and s034 is approved and closed. Please provide email confirmation that you acknowledge this request

DeviceBelotero Balance
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantMERZ NORTH AMERICA, INC
Date Received2020-09-29
Decision Date2020-10-29
PMAP090016
SupplementS043
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MERZ NORTH AMERICA, INC 4133 Courtney Road suite 10 franksville, WI 53126

Supplemental Filings

Supplement NumberDateSupplement Type
P090016Original Filing
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
07640123791213 P090016 000
07640123791213 P090016 000
07640123791213 P090016 000
07640123791213 P090016 000
07640123791213 P090016 000
07640123791213 P090016 000
07640123791213 P090016 000
07640123791213 P090016 000
07640123791213 P090016 000
07640123791213 P090016 000
07640123791121 P090016 000
07640123791121 P090016 000
07640123791121 P090016 000
07640123791121 P090016 000
07640123791121 P090016 000
07640123791121 P090016 000
07640123791121 P090016 000
07640123791121 P090016 000
07640123791121 P090016 000
07640123791121 P090016 000
07640123791121 P090016 000
07640123791121 P090016 000
07640123791121 P090016 000
07640123791121 P090016 000
07640123791213 P090016 000

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