Approval for the modification of the manufacturing process for hyalgan for producing hyaluronate by a bacterial fermentation and is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy, and to simple analgesics, e. G. , acetaminophen.
| Device | HYALGAN |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | FIDIA FARMACEUTICI SPA |
| Date Received | 2007-06-20 |
| Decision Date | 2008-05-01 |
| PMA | P950027 |
| 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 | FIDIA FARMACEUTICI SPA via Ponte Della Fabbrica 3/a abano Terme, Padua (pd) 35031 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P950027 | | Original Filing |
| S018 |
2022-12-23 |
30-day Notice |
| S017 |
2022-09-08 |
30-day Notice |
| S016 |
2022-07-11 |
30-day Notice |
| S015 |
2016-08-01 |
30-day Notice |
| S014 |
2013-08-29 |
Real-time Process |
| S013 | | |
| S012 |
2010-02-26 |
30-day Notice |
| S011 |
2008-02-20 |
Real-time Process |
| S010 |
2007-12-07 |
Special (immediate Track) |
| S009 |
2007-06-20 |
Normal 180 Day Track |
| S008 | | |
| S007 | | |
| S006 |
2005-01-07 |
Real-time Process |
| S005 | | |
| S004 |
1998-12-23 |
Normal 180 Day Track |
| S003 |
1998-08-24 |
Normal 180 Day Track |
| S002 |
1998-08-05 |
Normal 180 Day Track |
| S001 |
1997-06-24 |
Normal 180 Day Track |
NIH GUDID Devices