Juvéderm Ultra, Ultra XC, Ultra Plus, and Ultra Plus XC

FDA Premarket Approval P050047 S077

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 revisions to the clinician labeling of juvéderm® ultra, juvéderm® ultra xc, juvéderm® ultra plus, juvéderm® ultra plus xc, juvéderm® vollure xc, and juvéderm® volbella xc to include updated safety information based on post marketing surveillance data

DeviceJuvéderm Ultra, Ultra XC, Ultra Plus, and Ultra Plus XC
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantAllergan
Date Received2020-06-19
Decision Date2020-07-17
PMAP050047
SupplementS077
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 Allergan 2525 Dupont Dr. irvine, CA 92612

Supplemental Filings

Supplement NumberDateSupplement Type
P050047Original Filing
S077 2020-06-19 Special (immediate Track)
S076 2020-05-01 Special (immediate Track)
S075 2020-04-24 30-day Notice
S074 2019-11-15 30-day Notice
S073 2019-09-20 30-day Notice
S072 2019-07-29 30-day Notice
S071 2019-05-28 Special (immediate Track)
S070 2019-04-10 30-day Notice
S069
S068 2019-03-07 Special (immediate Track)
S067 2019-01-03 30-day Notice
S066 2018-12-17 Real-time Process
S065 2018-04-05 30-day Notice
S064 2018-04-02 30-day Notice
S063 2018-03-08 30-day Notice
S062 2018-01-22 30-day Notice
S061 2017-10-24 30-day Notice
S060 2017-05-18 30-day Notice
S059 2017-05-03 30-day Notice
S058 2017-03-20 135 Review Track For 30-day Notice
S057 2017-03-16 30-day Notice
S056 2017-02-09 135 Review Track For 30-day Notice
S055 2016-12-23 30-day Notice
S054 2016-11-21 30-day Notice
S053 2016-05-02 30-day Notice
S052 2016-04-04 Special (immediate Track)
S051 2015-09-28 30-day Notice
S050 2015-08-31 Special (immediate Track)
S049
S048 2015-06-10 Real-time Process
S047 2015-04-28 30-day Notice
S046 2015-02-24 30-day Notice
S045 2015-02-03 30-day Notice
S044 2015-01-27 Panel Track
S043 2014-11-24 Special (immediate Track)
S042 2014-11-03 Special (immediate Track)
S041 2014-07-01 30-day Notice
S040 2014-06-16 Normal 180 Day Track
S039 2014-06-13 30-day Notice
S038 2014-05-27 30-day Notice
S037 2014-05-01 135 Review Track For 30-day Notice
S036 2014-03-20 30-day Notice
S035 2014-01-23 30-day Notice
S034 2014-01-14 30-day Notice
S033 2013-12-04 135 Review Track For 30-day Notice
S032 2013-08-28 30-day Notice
S031 2013-08-03 Real-time Process
S030 2012-12-26 Real-time Process
S029
S028 2012-09-27 30-day Notice
S027 2012-06-25 30-day Notice
S026
S025 2012-05-11 30-day Notice
S024 2012-03-29 30-day Notice
S023 2012-02-21 30-day Notice
S022 2012-01-25 Special (immediate Track)
S021 2012-01-24 30-day Notice
S020 2011-09-26 Real-time Process
S019 2011-08-01 Real-time Process
S018 2011-07-07 135 Review Track For 30-day Notice
S017 2011-06-22 30-day Notice
S016 2011-04-01 135 Review Track For 30-day Notice
S015 2011-03-09 Special (immediate Track)
S014 2011-01-14 135 Review Track For 30-day Notice
S013 2010-08-25 30-day Notice
S012 2010-08-16 30-day Notice
S011 2009-11-25 30-day Notice
S010 2009-11-17 135 Review Track For 30-day Notice
S009 2009-08-05 30-day Notice
S008 2009-06-23 Real-time Process
S007 2009-01-12 135 Review Track For 30-day Notice
S006 2009-01-07 30-day Notice
S005 2008-08-18 Normal 180 Day Track
S004
S003 2008-04-07 Real-time Process
S002 2007-11-13 Special (immediate Track)
S001 2007-04-27 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
30888628000104 P050047 008
30888628000104 P050047 008
30888628000036 P050047 008
30888628000074 P050047 008
30888628000050 P050047 008
30888628000036 P050047 008
30888628000050 P050047 008
30888628000074 P050047 008
30888628000081 P050047 013
30888628000111 P050047 013
30888628000111 P050047 013
30888628000081 P050047 013
10888628044777 P050047 066
10888628044753 P050047 066
10888628044739 P050047 066

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