Approval for changing the trade name o the product from nuflexxa to euflexxa. 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 | EUFLEXXA |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | FERRING PHARMACEUTICALS, INC. |
| Date Received | 2005-10-05 |
| Decision Date | 2005-10-20 |
| PMA | P010029 |
| Supplement | S002 |
| 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 | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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