Approval for a manufacturing site change from the previous facility in west cummings park, woburn, massachusetts to the new facility located in bedford, massachusetts. In addition, the supplement requested approval to change the terminal sterilization method of the product from e-beam controlled depth sterilization to vaporized hydrogen peroxide (vhp) gas sterilization.
| Device | STAARVISC II & SHELLGEL SODIUM HYAURONATE |
| Classification Name | Aid, Surgical, Viscoelastic |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Anika Therapeutics, Inc. |
| Date Received | 2009-05-27 |
| Decision Date | 2012-03-27 |
| PMA | P000046 |
| Supplement | S015 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Anika Therapeutics, Inc. 32 Wiggins Avenue bedford, MA 01730 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P000046 | | Original Filing |
| S030 |
2021-11-23 |
Normal 180 Day Track No User Fee |
| S029 |
2021-07-29 |
Normal 180 Day Track No User Fee |
| S028 |
2021-05-04 |
30-day Notice |
| S027 |
2019-05-24 |
Real-time Process |
| S026 |
2017-02-14 |
Normal 180 Day Track No User Fee |
| S025 |
2014-06-10 |
30-day Notice |
| S024 |
2014-06-02 |
30-day Notice |
| S023 |
2014-01-15 |
Normal 180 Day Track No User Fee |
| S022 |
2013-12-27 |
30-day Notice |
| S021 |
2013-12-26 |
30-day Notice |
| S020 |
2011-11-04 |
30-day Notice |
| S019 |
2010-11-01 |
Normal 180 Day Track No User Fee |
| S018 |
2010-11-03 |
30-day Notice |
| S017 |
2010-09-30 |
Normal 180 Day Track No User Fee |
| S016 |
2009-10-02 |
Normal 180 Day Track No User Fee |
| S015 |
2009-05-27 |
Normal 180 Day Track |
| S014 |
2006-07-24 |
30-day Notice |
| S013 |
2006-01-03 |
30-day Notice |
| S012 |
2005-09-07 |
Special (immediate Track) |
| S011 |
2005-07-07 |
Special (immediate Track) |
| S010 |
2004-06-17 |
30-day Notice |
| S009 |
2004-05-07 |
30-day Notice |
| S008 |
2003-04-25 |
30-day Notice |
| S007 |
2002-11-27 |
Normal 180 Day Track |
| S006 |
2002-10-15 |
Normal 180 Day Track |
| S005 | | |
| S004 |
2002-05-21 |
Normal 180 Day Track |
| S003 |
2002-04-17 |
Real-time Process |
| S002 |
2002-03-18 |
Normal 180 Day Track |
| S001 |
2001-05-10 |
Real-time Process |
NIH GUDID Devices