Approval for modifying the specifications for the active ingredient (sodium hyaluronate) by eliminating the abnormal toxicity test and replacing the rabbit pyrogen test with the bacterial endotoxins test (limulus amoebocyte lysate (lal) test) and modifying the specifications for the finished product to replace the rabbit pyrogen test with the lal test.
| Device | HYALGAN |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | FIDIA FARMACEUTICI SPA |
| Date Received | 2005-01-07 |
| Decision Date | 2005-07-19 |
| PMA | P950027 |
| Supplement | S006 |
| Product Code | MOZ |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| 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