The following changes: 1) replacement of the gamma radiation source and requalification of sterilization at the dagneux france facility; 2) packaging modification for the raw material, including a new bag supplier and the introduction of a new bagging configuration; and 3) replacement of the gamma radiation source and requalification at the sablÉ france facility.
| Device | SCULPTRA AND SCULPTRA AESTHETIC |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Q-Med AB |
| Date Received | 2013-07-22 |
| Decision Date | 2013-08-16 |
| PMA | P030050 |
| Supplement | S018 |
| 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 | Q-Med AB seminariegatan 21 uppsala SE-75-752- |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030050 | | Original Filing |
| S038 |
2021-12-22 |
Normal 180 Day Track No User Fee |
| S037 | | |
| S036 |
2021-04-01 |
30-day Notice |
| S035 | | |
| S034 | | |
| S033 |
2020-11-18 |
30-day Notice |
| S032 | | |
| S031 |
2020-01-31 |
30-day Notice |
| S030 |
2020-01-30 |
30-day Notice |
| S029 |
2018-05-02 |
30-day Notice |
| S028 |
2017-12-05 |
Normal 180 Day Track No User Fee |
| S027 |
2017-11-20 |
30-day Notice |
| S026 |
2017-02-08 |
135 Review Track For 30-day Notice |
| S025 |
2016-07-08 |
Special (immediate Track) |
| S024 |
2016-06-10 |
30-day Notice |
| S023 | | |
| S022 |
2014-07-17 |
135 Review Track For 30-day Notice |
| S021 |
2014-04-01 |
30-day Notice |
| S020 |
2014-01-22 |
30-day Notice |
| S019 |
2013-12-23 |
30-day Notice |
| S018 |
2013-07-22 |
30-day Notice |
| S017 |
2013-04-05 |
Normal 180 Day Track No User Fee |
| S016 |
2013-03-25 |
Normal 180 Day Track No User Fee |
| S015 |
2013-03-04 |
135 Review Track For 30-day Notice |
| S014 |
2012-12-20 |
Real-time Process |
| S013 |
2012-12-18 |
30-day Notice |
| S012 | | |
| S011 |
2011-05-20 |
135 Review Track For 30-day Notice |
| S010 |
2011-03-25 |
30-day Notice |
| S009 |
2010-12-06 |
Normal 180 Day Track No User Fee |
| S008 |
2010-05-19 |
Normal 180 Day Track No User Fee |
| S007 |
2009-08-19 |
Normal 180 Day Track No User Fee |
| S006 |
2009-10-09 |
Real-time Process |
| S005 |
2009-08-19 |
Normal 180 Day Track No User Fee |
| S004 |
2008-12-17 |
Normal 180 Day Track No User Fee |
| S003 |
2008-03-11 |
Normal 180 Day Track No User Fee |
| S002 |
2006-07-28 |
Panel Track |
| S001 |
2004-10-04 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices