Bellafill Dermal Filler

FDA Premarket Approval P020012 S036

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 a revision to the clinician labeling of bellafill dermal filler to include updated safety information based upon post marketing surveillance data.

DeviceBellafill Dermal Filler
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantSUNEVA MEDICAL, INC.
Date Received2020-05-22
Decision Date2020-06-19
PMAP020012
SupplementS036
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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
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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.