Approval for the change in product trade name. The device, as modified, will be marketed under the trade name elevess and is indicated for injection into the mid to deep dermis for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
| Device | ELEVESS |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Anika Therapeutics, Inc. |
| Date Received | 2007-09-19 |
| Decision Date | 2007-10-03 |
| PMA | P050033 |
| Supplement | S005 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Anika Therapeutics, Inc. 32 Wiggins Avenue bedford, MA 01730 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050033 | | Original Filing |
| S020 |
2015-09-29 |
Special (immediate Track) |
| S019 |
2015-03-12 |
30-day Notice |
| S018 |
2015-01-29 |
135 Review Track For 30-day Notice |
| S017 |
2014-05-01 |
30-day Notice |
| S016 |
2014-05-01 |
Real-time Process |
| S015 |
2012-05-04 |
135 Review Track For 30-day Notice |
| S014 |
2011-12-23 |
Special (immediate Track) |
| S013 |
2011-06-20 |
Normal 180 Day Track No User Fee |
| S012 |
2011-04-12 |
135 Review Track For 30-day Notice |
| S011 |
2010-11-03 |
30-day Notice |
| S010 | | |
| S009 |
2010-08-04 |
Special (immediate Track) |
| S008 |
2009-09-08 |
Special (immediate Track) |
| S007 |
2009-05-15 |
Normal 180 Day Track No User Fee |
| S006 |
2009-02-18 |
Normal 180 Day Track No User Fee |
| S005 |
2007-09-19 |
Normal 180 Day Track No User Fee |
| S004 |
2007-09-17 |
Real-time Process |
| S003 |
2007-09-06 |
135 Review Track For 30-day Notice |
| S002 |
2007-05-31 |
Normal 180 Day Track No User Fee |
| S001 |
2007-01-03 |
Normal 180 Day Track |
NIH GUDID Devices