Changes to the naha assay for belotero balance dermal filler and belotero balance (+) lidocaine dermal filler, including the introduction of 125 ml hdpe bottles, the use of two series of 40 samples from each series, and the use of an alternate water source for testing
| Device | Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | MERZ NORTH AMERICA, INC |
| Date Received | 2020-01-08 |
| Decision Date | 2020-02-07 |
| PMA | P090016 |
| Supplement | S038 |
| 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 | MERZ NORTH AMERICA, INC 4133 Courtney Road suite 10 franksville, WI 53126 |
Supplemental Filings
| 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 |
NIH GUDID Devices