Approval for some labeling updates to improve the safe use of the device.
| Device | JUVEDERM HYALURONATE GEL IMPLANTS |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Allergan |
| Date Received | 2011-03-09 |
| Decision Date | 2011-03-25 |
| PMA | P050047 |
| Supplement | S015 |
| 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 | Yes |
| 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