Change in manufacturing to shorten the time required for the concentration step during formulation by slightly increasing the pressure and reducing the concentration time in the uf (ultrafiltration) unit.
| Device | EUFLEXXA (1% Sodium Hyaluronate) |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | FERRING PHARMACEUTICALS, INC. |
| Date Received | 2020-04-02 |
| Decision Date | 2020-04-16 |
| PMA | P010029 |
| Supplement | S030 |
| Product Code | MOZ |
| Advisory Committee | Orthopedic |
| Supplement Type | 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