Approval for the revision of a precaution statement in your product label to state: sculptra aesthetic should only be used by a healthcare practitioner trained to correct shallow to deep nasolabial contour deficiencies and other facial wrinkles, in which deep dermal grid pattern (cross-hatch) injection technique is appropriate, after the healthcare practitioner is fully familiar with the product, was, product educational materials, and the entire package insert and patient labeling. The device, as modified, will be marketed under the trade name sculptra aesthetic and is indicated for use in immune-competent people as a single regimen for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate.
| Device | SCULPTRA AESTHETIC |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Q-Med AB |
| Date Received | 2012-12-20 |
| Decision Date | 2013-05-28 |
| PMA | P030050 |
| Supplement | S014 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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