Approval for changes to the directions for use and patient labeling including updated postmarket surveillance data as well as other changes to harmonize pertinent content across juvederm labeling documents. Minor typographical revisions and clarifications are also included.
| Device | JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Allergan |
| Date Received | 2016-04-04 |
| Decision Date | 2016-04-29 |
| PMA | P050047 |
| Supplement | S052 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Allergan 2525 Dupont Dr. irvine, CA 92612 |
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