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

FDA Premarket Approval P050047 S085

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

DeviceJuvéderm Ultra, Ultra XC and Ultra Plus XC, Juvéderm Ultra XC
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantAllergan2525 Dupont Dr.irvine, CA 92612 PMA NumberP050047 Supplement NumberS085 Date Received04/01/2022 Decision Date04/28/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-01
Decision Date2022-04-28
PMAP050047
SupplementS085
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressAllergan
2525 Dupont Dr.
irvine, CA 92612 PMA NumberP050047 Supplement NumberS085 Date Received04/01/2022 Decision Date04/28/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
implementation Of Additional Duplicate Manufacturing Equipment For The Juvderm Injectable Gel Products Approved Under P050047 And P110033

Supplemental Filings

Supplement NumberDateSupplement Type
P050047Original Filing
S085 2022-04-01 30-day Notice
S084
S083
S082 2021-06-29 30-day Notice
S081 2021-05-27 Special (immediate Track)
S080
S079 2020-10-30 Special (immediate Track)
S078 2020-09-29 30-day Notice
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
30888628000074 P050047 008
30888628000050 P050047 008
30888628000036 P050047 008
30888628000111 P050047 013
30888628000081 P050047 013
10888628044777 P050047 066
10888628044753 P050047 066
10888628044739 P050047 066

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