Approval for the bellafill. This device is indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years.
| Device | BELLAFILL |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | SUNEVA MEDICAL, INC. |
| Date Received | 2014-05-16 |
| Decision Date | 2014-12-23 |
| Notice Date | 2014-12-30 |
| PMA | P020012 |
| Supplement | S009 |
| Product Code | LMH |
| Docket Number | 14M-2376 |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | SUNEVA MEDICAL, INC. 5879 Pacific Center Blvd. san Diego, CA 92121 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
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