Bellafill Dermal Filler

FDA Premarket Approval P020012 S038

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

Implementation of a new chromatography equipment for hydroxyproline/collagen content and lidocaine hydrochloride content in-process and lot release quality control testing

DeviceBellafill Dermal Filler
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantSUNEVA MEDICAL, INC.
Date Received2021-04-16
Decision Date2021-05-14
PMAP020012
SupplementS038
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address SUNEVA MEDICAL, INC. 5879 Pacific Center Blvd. san Diego, CA 92121

Supplemental Filings

Supplement NumberDateSupplement Type
P020012Original Filing
S038 2021-04-16 30-day Notice
S037
S036 2020-05-22 Special (immediate Track)
S035 2019-09-26 30-day Notice
S034 2019-09-17 30-day Notice
S033
S032
S031 2019-06-12 30-day Notice
S030 2019-06-11 30-day Notice
S029 2019-04-05 Special (immediate Track)
S028 2019-03-05 30-day Notice
S027
S026 2018-06-29 30-day Notice
S025 2018-03-27 30-day Notice
S024 2018-03-16 30-day Notice
S023 2018-03-13 30-day Notice
S022 2018-03-07 30-day Notice
S021 2018-03-05 135 Review Track For 30-day Notice
S020
S019 2018-02-22 Special (immediate Track)
S018 2018-01-25 135 Review Track For 30-day Notice
S017 2017-12-04 30-day Notice
S016
S015 2017-09-01 30-day Notice
S014 2017-06-15 Normal 180 Day Track
S013 2017-03-06 30-day Notice
S012 2016-02-24 135 Review Track For 30-day Notice
S011 2015-02-24 Normal 180 Day Track No User Fee
S010
S009 2014-05-16 Panel Track
S008 2013-08-16 Normal 180 Day Track No User Fee
S007 2013-02-07 Normal 180 Day Track No User Fee
S006 2011-12-28 Normal 180 Day Track No User Fee
S005
S004
S003 2008-04-28 Normal 180 Day Track No User Fee
S002
S001

NIH GUDID Devices

Device IDPMASupp
00350224000028 P020012 008
00350224000004 P020012 008
10350224000032 P020012 008

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