Approval for modification of labeling and additional information about the current clinical experience of the device as detailed in amendment received 12/10/99.
Device | HYALGAN(R) |
Classification Name | Acid, Hyaluronic, Intraarticular |
Generic Name | Acid, Hyaluronic, Intraarticular |
Applicant | FIDIA FARMACEUTICI SPA |
Date Received | 1998-08-24 |
Decision Date | 1999-12-18 |
PMA | P950027 |
Supplement | S003 |
Product Code | MOZ |
Advisory Committee | Orthopedic |
Supplement Type | Normal 180 Day 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