Approval for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.
Device | JUVEDERM VOLLURE XC |
Classification Name | Implant, Dermal, For Aesthetic Use |
Generic Name | Implant, Dermal, For Aesthetic Use |
Applicant | Allergan |
Date Received | 2015-09-30 |
Decision Date | 2017-03-17 |
Notice Date | 2017-03-22 |
PMA | P110033 |
Supplement | S020 |
Product Code | LMH |
Docket Number | 17M-1714 |
Advisory Committee | General & Plastic Surgery |
Supplement Type | Panel 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 |
Summary: | Summary of Safety and Effectiveness |
Labeling: | Labeling Labeling Part 2 |
Approval Order: | Approval Order |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P110033 | | Original Filing |
S067 |
2022-07-07 |
30-day Notice |
S066 |
2022-04-01 |
30-day Notice |
S065 | | |
S064 | | |
S063 | | |
S062 |
2021-06-29 |
Normal 180 Day Track No User Fee |
S061 |
2021-06-29 |
30-day Notice |
S060 |
2021-05-27 |
Special (immediate Track) |
S059 | | |
S058 | | |
S057 |
2020-10-30 |
Special (immediate Track) |
S056 |
2020-09-29 |
30-day Notice |
S055 |
2020-06-19 |
Special (immediate Track) |
S054 |
2020-04-24 |
30-day Notice |
S053 | | |
S052 |
2019-12-20 |
Real-time Process |
S051 |
2019-11-15 |
30-day Notice |
S050 |
2019-09-20 |
30-day Notice |
S049 | | |
S048 |
2019-07-29 |
30-day Notice |
S047 | | |
S046 |
2019-05-28 |
Special (immediate Track) |
S045 |
2019-04-10 |
30-day Notice |
S044 | | |
S043 |
2019-03-07 |
Special (immediate Track) |
S042 | | |
S041 |
2019-01-03 |
30-day Notice |
S040 | | |
S039 |
2018-04-05 |
30-day Notice |
S038 |
2018-04-02 |
30-day Notice |
S037 |
2018-03-08 |
30-day Notice |
S036 |
2018-01-22 |
30-day Notice |
S035 |
2017-11-20 |
30-day Notice |
S034 |
2017-10-24 |
30-day Notice |
S033 |
2017-08-21 |
135 Review Track For 30-day Notice |
S032 | | |
S031 |
2017-08-04 |
Real-time Process |
S030 |
2017-05-18 |
30-day Notice |
S029 |
2017-05-03 |
30-day Notice |
S028 |
2017-03-20 |
135 Review Track For 30-day Notice |
S027 |
2017-03-16 |
30-day Notice |
S026 |
2017-02-09 |
135 Review Track For 30-day Notice |
S025 |
2016-12-23 |
30-day Notice |
S024 |
2016-11-21 |
30-day Notice |
S023 |
2016-06-14 |
Real-time Process |
S022 |
2016-06-09 |
135 Review Track For 30-day Notice |
S021 |
2016-03-21 |
Normal 180 Day Track No User Fee |
S020 |
2015-09-30 |
Panel Track |
S019 |
2015-08-31 |
Special (immediate Track) |
S018 |
2015-08-03 |
Panel Track |
S017 | | |
S016 |
2015-05-11 |
30-day Notice |
S015 |
2015-06-10 |
Real-time Process |
S014 |
2015-04-28 |
30-day Notice |
S013 |
2015-02-24 |
30-day Notice |
S012 |
2014-11-03 |
Special (immediate Track) |
S011 |
2014-07-28 |
135 Review Track For 30-day Notice |
S010 |
2014-07-01 |
30-day Notice |
S009 |
2014-05-27 |
30-day Notice |
S008 |
2014-05-13 |
30-day Notice |
S007 |
2014-05-01 |
135 Review Track For 30-day Notice |
S006 |
2014-03-31 |
30-day Notice |
S005 |
2014-03-20 |
30-day Notice |
S004 |
2014-01-23 |
30-day Notice |
S003 |
2014-01-14 |
30-day Notice |
S002 |
2013-11-25 |
135 Review Track For 30-day Notice |
S001 |
2013-11-06 |
30-day Notice |
NIH GUDID Devices