1) changed contract test lab and associated sop for residual monomer in unprocessed pmma microspheres; 2) changed contract test lab and associated sop for residual monomer in processed non-sterile pmma microspheres; and 3) added reference to internal manufacturing document and clarified rejectcriteria for finished product specification.
| Device | Bellafill Dermal Filter |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | SUNEVA MEDICAL, INC. |
| Date Received | 2017-03-06 |
| Decision Date | 2017-04-06 |
| PMA | P020012 |
| Supplement | S013 |
| 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 | SUNEVA MEDICAL, INC. 5879 Pacific Center Blvd. san Diego, CA 92121 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P020012 | | Original Filing |
| S041 |
2022-07-08 |
30-day Notice |
| S040 |
2021-08-20 |
135 Review Track For 30-day Notice |
| S039 | | |
| S038 |
2021-04-16 |
30-day Notice |
| S037 | | |
| S036 |
2020-05-22 |
Special (immediate Track) |
| S035 |
2019-09-26 |
30-day Notice |
| S034 |
2019-09-17 |
30-day Notice |
| S033 | | |
| S032 | | |
| S031 |
2019-06-12 |
30-day Notice |
| S030 |
2019-06-11 |
30-day Notice |
| S029 |
2019-04-05 |
Special (immediate Track) |
| S028 |
2019-03-05 |
30-day Notice |
| S027 | | |
| S026 |
2018-06-29 |
30-day Notice |
| S025 |
2018-03-27 |
30-day Notice |
| S024 |
2018-03-16 |
30-day Notice |
| S023 |
2018-03-13 |
30-day Notice |
| S022 |
2018-03-07 |
30-day Notice |
| S021 |
2018-03-05 |
135 Review Track For 30-day Notice |
| S020 | | |
| S019 |
2018-02-22 |
Special (immediate Track) |
| S018 |
2018-01-25 |
135 Review Track For 30-day Notice |
| S017 |
2017-12-04 |
30-day Notice |
| S016 | | |
| S015 |
2017-09-01 |
30-day Notice |
| S014 |
2017-06-15 |
Normal 180 Day Track |
| S013 |
2017-03-06 |
30-day Notice |
| S012 |
2016-02-24 |
135 Review Track For 30-day Notice |
| S011 |
2015-02-24 |
Normal 180 Day Track No User Fee |
| S010 | | |
| S009 |
2014-05-16 |
Panel Track |
| S008 |
2013-08-16 |
Normal 180 Day Track No User Fee |
| S007 |
2013-02-07 |
Normal 180 Day Track No User Fee |
| S006 |
2011-12-28 |
Normal 180 Day Track No User Fee |
| S005 | | |
| S004 | | |
| S003 |
2008-04-28 |
Normal 180 Day Track No User Fee |
| S002 | | |
| S001 | | |
NIH GUDID Devices