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.
Change to the bacterial endotoxins (be) acceptance limit for the glass syringe associated with change in be test method
| Device | GELSYN-3 |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | IBSA INSTITUT BIOCHIMIQUE SA |
| Date Received | 2020-09-04 |
| Decision Date | 2020-10-08 |
| PMA | P110005 |
| Supplement | S006 |
| 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 | IBSA INSTITUT BIOCHIMIQUE SA via Al Ponte 13, Ch-6903 lugano Ticino 6903 |
| 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 |