Belotero Balance Dermal Filler

FDA Premarket Approval P090016 S035

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

Approval for qualification of an alternative supplier of needles (27g x 1/2", 30g x 1/2") and modification of associated secondary packaging components to accommodate the new needles.

DeviceBelotero Balance Dermal Filler
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantMERZ NORTH AMERICA, INC
Date Received2019-08-23
Decision Date2020-02-06
PMAP090016
SupplementS035
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type135 Review Track For 30-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
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

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