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 | Bellafill® Dermal Filler |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | SUNEVA MEDICAL, INC.5879 Pacific Center Blvd.san Diego, CA 92121 PMA NumberP020012 Supplement NumberS041 Date Received07/08/2022 Decision Date08/05/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-07-08 |
| Decision Date | 2022-08-05 |
| PMA | P020012 |
| Supplement | S041 |
| 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 | SUNEVA MEDICAL, INC. 5879 Pacific Center Blvd. san Diego, CA 92121 PMA NumberP020012 Supplement NumberS041 Date Received07/08/2022 Decision Date08/05/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement implementing An Alternate Particle Testing Method As The Primary Test Method For PMMA Microsphere Count And Size Distribution Testing |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00350224000028 | P020012 | 008 |
| 00350224000004 | P020012 | 008 |
| 10350224000032 | P020012 | 008 |
| 10350224000148 | P020012 | 039 |