Qualification of an alternative supplier of needles and modification of associated secondary packaging components to accommodate the new needles.
| Device | Belotero Balance + Lidocaine |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | MERZ NORTH AMERICA, INC |
| Date Received | 2021-09-15 |
| Decision Date | 2021-10-13 |
| PMA | P090016 |
| Supplement | S046 |
| 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 |
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