Approval for the sterile sodium hyaluronate (naha) to be stored in sterile, disposable polyethylene bags for up to 48 hours prior to filling the syringes. The device, as modified, will be marketed under the trade name euflexxa and is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e. G. , acetaminophen.
| Device | EUFLEXXA 1% SODIUM HYALURONATE |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | FERRING PHARMACEUTICALS, INC. |
| Date Received | 2008-05-02 |
| Decision Date | 2009-07-01 |
| PMA | P010029 |
| Supplement | S007 |
| Product Code | MOZ |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Orthopedic |
| 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 | FERRING PHARMACEUTICALS, INC. 100 Interpace Parkway parsippany, NJ 07054 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P010029 | | Original Filing |
| S030 |
2020-04-02 |
30-day Notice |
| S029 |
2019-12-09 |
30-day Notice |
| S028 |
2019-04-05 |
30-day Notice |
| S027 |
2018-08-22 |
Real-time Process |
| S026 |
2018-03-29 |
30-day Notice |
| S025 |
2017-06-20 |
Normal 180 Day Track No User Fee |
| S024 |
2015-04-23 |
30-day Notice |
| S023 |
2015-03-06 |
30-day Notice |
| S022 |
2015-02-09 |
30-day Notice |
| S021 |
2014-12-24 |
30-day Notice |
| S020 |
2014-04-28 |
30-day Notice |
| S019 |
2014-02-20 |
30-day Notice |
| S018 |
2013-11-13 |
30-day Notice |
| S017 |
2013-05-08 |
30-day Notice |
| S016 |
2013-01-15 |
30-day Notice |
| S015 |
2012-04-05 |
30-day Notice |
| S014 |
2012-03-05 |
30-day Notice |
| S013 |
2011-12-29 |
30-day Notice |
| S012 |
2011-03-02 |
30-day Notice |
| S011 |
2009-12-07 |
30-day Notice |
| S010 |
2009-11-17 |
135 Review Track For 30-day Notice |
| S009 |
2009-11-09 |
30-day Notice |
| S008 |
2009-03-30 |
Panel Track |
| S007 |
2008-05-02 |
135 Review Track For 30-day Notice |
| S006 |
2007-03-22 |
Real-time Process |
| S005 | | |
| S004 |
2006-09-18 |
Real-time Process |
| S003 | | |
| S002 |
2005-10-05 |
Normal 180 Day Track No User Fee |
| S001 |
2005-01-13 |
Normal 180 Day Track |
NIH GUDID Devices