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 (+) Lidocaine |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP090016 Supplement NumberS049 Date Received07/21/2022 Decision Date10/26/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-07-21 |
| Decision Date | 2022-10-26 |
| PMA | P090016 |
| Supplement | S049 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | MERZ NORTH AMERICA, INC 4133 Courtney Road suite 10 franksville, WI 53126 PMA NumberP090016 Supplement NumberS049 Date Received07/21/2022 Decision Date10/26/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductYes Approval Order Statement Approval To Increase The Tolerance Range For The Lidocaine Hydrochloride Specification From 3.00 ± 5% Mg/mL (2.85-3.15 Mg/mL) To 3.0 ± 10% Mg/mL (2.7 - 3.3 Mg/mL). |
| 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 |