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 | Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP090016 Supplement NumberS048 Date Received04/05/2022 Decision Date05/05/2022 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 | 2022-04-05 |
| Decision Date | 2022-05-05 |
| PMA | P090016 |
| Supplement | S048 |
| 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 | No |
| Applicant Address | MERZ NORTH AMERICA, INC 4133 Courtney Road suite 10 franksville, WI 53126 PMA NumberP090016 Supplement NumberS048 Date Received04/05/2022 Decision Date05/05/2022 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 ProductNo Approval Order Statement to Modify The Depyrogenation Cycle For The Equipment Used In The Manufacturing Of Belotero Balance Dermal Filler And Belotero Balance With Lidocaine Dermal Filler |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090016 | Original Filing | |
| S049 | 2022-07-21 | Normal 180 Day Track |
| S048 | 2022-04-05 | 30-day Notice |
| S047 | ||
| S046 | 2021-09-15 | 30-day Notice |
| S045 | ||
| S044 | ||
| S043 | 2020-09-29 | 30-day Notice |
| S042 | ||
| S041 | ||
| S040 | ||
| S039 | ||
| S038 | 2020-01-08 | 30-day Notice |
| S037 | ||
| S036 | 2019-11-06 | Real-time Process |
| S035 | 2019-08-23 | 135 Review Track For 30-day Notice |
| S034 | ||
| S033 | 2019-07-02 | 30-day Notice |
| S032 | 2019-05-23 | 30-day Notice |
| S031 | 2018-09-25 | 30-day Notice |
| S030 | 2018-06-25 | 30-day Notice |
| S029 | ||
| S028 | 2018-04-20 | Normal 180 Day Track |
| S027 | 2018-03-05 | 30-day Notice |
| S026 | 2018-03-05 | 30-day Notice |
| S025 | 2017-10-12 | Normal 180 Day Track No User Fee |
| S024 | ||
| S023 | 2017-03-21 | 30-day Notice |
| S022 | 2016-11-23 | 30-day Notice |
| S021 | ||
| S020 | 2016-03-17 | 30-day Notice |
| S019 | 2015-12-01 | 135 Review Track For 30-day Notice |
| S018 | 2015-11-04 | Special (immediate Track) |
| S017 | 2015-06-05 | Special (immediate Track) |
| S016 | 2015-06-02 | Real-time Process |
| S015 | 2015-04-02 | 30-day Notice |
| S014 | 2015-02-19 | 30-day Notice |
| S013 | 2014-11-28 | 135 Review Track For 30-day Notice |
| S012 | 2014-08-07 | 30-day Notice |
| S011 | 2014-08-06 | 30-day Notice |
| S010 | 2014-08-05 | 30-day Notice |
| S009 | 2014-04-11 | Normal 180 Day Track No User Fee |
| S008 | 2014-01-14 | Real-time Process |
| S007 | 2013-06-19 | 30-day Notice |
| S006 | 2013-02-21 | 30-day Notice |
| S005 | 2013-01-28 | 30-day Notice |
| S004 | 2012-10-25 | Normal 180 Day Track No User Fee |
| S003 | 2012-10-10 | Normal 180 Day Track No User Fee |
| S002 | 2012-07-02 | Real-time Process |
| S001 | 2011-12-14 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 07640123791121 | P090016 | 000 |
| 07640123791213 | P090016 | 000 |
| 07640123791152 | P090016 | 000 |
| M2138700M05 | P090016 | 000 |