A change to the cleaning process of manufacturing equipment used during the manufacturing of juvéderm injectable gel products approved under pma p050047 and p110033
Device | Juvederm Injectable Gel Implants |
Generic Name | Implant, Dermal, For Aesthetic Use |
Applicant | Allergan |
Date Received | 2020-04-24 |
Decision Date | 2020-05-27 |
PMA | P050047 |
Supplement | S075 |
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 |
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