Implementation of an automated visual inspection process for juvederm volbella xc in the 0. 55 ml fill volume configuration.
Device | Juvederm Volbella XC |
Classification Name | Implant, Dermal, For Aesthetic Use |
Generic Name | Implant, Dermal, For Aesthetic Use |
Applicant | Allergan |
Date Received | 2017-11-20 |
Decision Date | 2017-12-14 |
PMA | P110033 |
Supplement | S035 |
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 |
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