Approval for the following changes in the label: 1) the addition of the trade name, hyalectin, for sodium hyaluronate in the device description; and 2) modifications to the contraindications, warnings and precautions to enhance the appropriate usage of the device.
| Device | HYALGAN |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | FIDIA FARMACEUTICI SPA |
| Date Received | 2007-12-07 |
| Decision Date | 2008-01-08 |
| PMA | P950027 |
| Supplement | S010 |
| Product Code | MOZ |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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