This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Voluma XC, Vollure XC, Volbella XC |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Allergan2525 Dupont Dr.irvine, CA 92612 PMA NumberP110033 Supplement NumberS067 Date Received07/07/2022 Decision Date08/05/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-07-07 |
| Decision Date | 2022-08-05 |
| PMA | P110033 |
| Supplement | S067 |
| 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 PMA NumberP110033 Supplement NumberS067 Date Received07/07/2022 Decision Date08/05/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement implementing An Additional Duplicate Syringe Assembly And Packaging Line For Manufacturing Juvéderm Injectable Gel Products Approved Under P050047 And P110033 |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 03770034301011 | P110033 | 000 |
| 30888628000012 | P110033 | 000 |
| 30840228302828 | P110033 | 000 |
| 03770034301004 | P110033 | 000 |
| 30840228302798 | P110033 | 018 |
| 10888628034471 | P110033 | 020 |
| 30840228302811 | P110033 | 020 |
| 10888628032446 | P110033 | 023 |
| 30840228302804 | P110033 | 023 |
| 10888628043565 | P110033 | 031 |
| 10888628043541 | P110033 | 031 |
| 30840228300060 | P110033 | 059 |
| 30840228302767 | P110033 | 059 |
| 30840228302835 | P110033 | 065 |
| 10840228300073 | P110033 | 065 |