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.
| Device | Juvéderm Ultra, Ultra XC and Ultra Plus XC, Juvéderm Ultra XC |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Allergan2525 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 Received | 2022-04-01 |
| Decision Date | 2022-04-28 |
| PMA | P050047 |
| Supplement | S085 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Allergan 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050047 | Original Filing | |
| S086 | 2022-07-07 | 30-day Notice |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 30840228302774 | P050047 | 005 |
| 30840228302781 | P050047 | 005 |
| 30888628000036 | P050047 | 008 |
| 30888628000050 | P050047 | 008 |
| 30888628000074 | P050047 | 008 |
| 30888628000104 | P050047 | 008 |
| 30888628000081 | P050047 | 013 |
| 30888628000111 | P050047 | 013 |
| 10888628044777 | P050047 | 066 |
| 10888628044753 | P050047 | 066 |
| 10888628044739 | P050047 | 066 |