Approval of an alternate supplier of a material used in the manufacture hydrelle.
| Device | HYDRELLE DERMAL FILLER |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | Anika Therapeutics, Inc. |
| Date Received | 2015-01-29 |
| Decision Date | 2015-11-03 |
| PMA | P050033 |
| Supplement | S018 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| 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