Approval for the addition of 0. 3% lidocaine into juvederm ultra and juvederm ultra plus. The device, as modified, will be marketed under the trade name juvederm ultra xc and juvederm ultra plus xc and is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
| Device | JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Allergan |
| Date Received | 2008-08-18 |
| Decision Date | 2010-01-07 |
| PMA | P050047 |
| Supplement | S005 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Allergan 2525 Dupont Dr. irvine, CA 92612 |
| Approval Order: | Approval Order |
Supplemental Filings
| 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 |
NIH GUDID Devices