This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for gel-syn. This device is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e. G. Acetaminophen).
| Device | SINOVIAL (SODIUM HYALURONATE 0.8%) |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | IBSA INSTITUT BIOCHIMIQUE SA |
| Date Received | 2011-02-10 |
| Decision Date | 2014-05-09 |
| Notice Date | 2014-05-29 |
| PMA | P110005 |
| Supplement | S |
| Product Code | MOZ |
| Docket Number | 14M-0691 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | IBSA INSTITUT BIOCHIMIQUE SA via Al Ponte 13, Ch-6903 lugano Ticino 6903 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110005 | Original Filing | |
| S012 | 2022-09-08 | Special (immediate Track) |
| S011 | 2022-02-16 | 30-day Notice |
| S010 | ||
| S009 | 2021-03-31 | 135 Review Track For 30-day Notice |
| S008 | 2021-03-03 | 30-day Notice |
| S007 | 2020-12-03 | 30-day Notice |
| S006 | 2020-09-04 | 30-day Notice |
| S005 | 2020-09-04 | 30-day Notice |
| S004 | 2020-06-29 | Special (immediate Track) |
| S003 | 2018-04-09 | Special (immediate Track) |
| S002 | 2017-01-19 | Normal 180 Day Track |
| S001 | 2016-03-25 | Real-time Process |