Approval for moving bioburden testing, conducted as part of routine quality control procedures for juvÉderm hyaluronate gel implants and juvÉderm voluma xc, from a contract laboratory to in-house.
| Device | JUVEDERM VOLUMA XC |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Allergan |
| Date Received | 2014-05-01 |
| Decision Date | 2014-09-11 |
| PMA | P110033 |
| Supplement | S007 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 135 Review Track For 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 |
|---|
| 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