Review to increase the number of syringes dried in the drying ovens and harmonize the number of syringes dried per drying cycle with the number of syringes sterilized per sterilization cycle.
| Device | JUVEDERM HYALURONATE GEL IMPLANTS |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Allergan |
| Date Received | 2012-03-29 |
| Decision Date | 2012-04-16 |
| PMA | P050047 |
| Supplement | S024 |
| 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 | 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