Approval for modifying the manufacturing process for orthovisc to one that produces sodium hyaluronate from bacterial fermentation. The device is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e. G. , acetaminophen).
| Device | ORTHOVISC SODIUM HYALURONATE |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | Anika Therapeutics, Inc. |
| Date Received | 2006-04-28 |
| Decision Date | 2007-10-26 |
| PMA | P030019 |
| Supplement | S009 |
| Product Code | MOZ |
| Advisory Committee | Orthopedic |
| 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 |
|---|
| P030019 | | Original Filing |
| S027 |
2022-10-12 |
30-day Notice |
| S026 |
2020-12-30 |
135 Review Track For 30-day Notice |
| S025 |
2020-11-09 |
30-day Notice |
| S024 | | |
| S023 |
2016-02-10 |
Special (immediate Track) |
| S022 |
2014-12-24 |
135 Review Track For 30-day Notice |
| S021 |
2014-06-25 |
30-day Notice |
| S020 |
2014-06-10 |
30-day Notice |
| S019 |
2014-05-15 |
30-day Notice |
| S018 |
2011-08-24 |
135 Review Track For 30-day Notice |
| S017 |
2010-11-03 |
135 Review Track For 30-day Notice |
| S016 | | |
| S015 |
2010-06-09 |
30-day Notice |
| S014 |
2009-06-16 |
Normal 180 Day Track No User Fee |
| S013 |
2006-07-24 |
135 Review Track For 30-day Notice |
| S012 |
2006-08-09 |
Normal 180 Day Track |
| S011 | | |
| S010 |
2006-07-10 |
30-day Notice |
| S009 |
2006-04-28 |
Normal 180 Day Track |
| S008 |
2006-01-03 |
30-day Notice |
| S007 | | |
| S006 |
2004-07-01 |
Normal 180 Day Track |
| S005 |
2004-06-17 |
30-day Notice |
| S004 |
2004-05-07 |
30-day Notice |
| S003 |
2004-03-16 |
30-day Notice |
| S002 | | |
| S001 |
2004-02-27 |
135 Review Track For 30-day Notice |
NIH GUDID Devices