This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | HYALGAN® (sodium hyaluronate) |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | FIDIA FARMACEUTICI SPAvia Ponte Della Fabbrica 3/aabano Terme, Padua (pd) 35031 PMA NumberP950027 Supplement NumberS018 Date Received12/23/2022 Decision Date01/19/2023 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-12-23 |
| Decision Date | 2023-01-19 |
| PMA | P950027 |
| Supplement | S018 |
| 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 | FIDIA FARMACEUTICI SPA via Ponte Della Fabbrica 3/a abano Terme, Padua (pd) 35031 PMA NumberP950027 Supplement NumberS018 Date Received12/23/2022 Decision Date01/19/2023 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Change To The Manufacturing Procedure, Including Methods For Filtration And Washes For The Sodium Hyaluronate Bulk Powder. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| M71389122072420A1 | P950027 | 006 |
| M71389122072412A1 | P950027 | 006 |
| M713891220724120 | P950027 | 006 |
| M713891220724200 | P950027 | 006 |
| 05060459970052 | P950027 | 014 |