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.
Approval for a labeling change to the product information leaflet for gelsyn-3 for incorporation of additional details in the instructions for removal of the syringe cap, securing of the needle to the syringe, and removal of the needle shield in preparation for injection of the product.
| Device | GELSYN-3 |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | IBSA INSTITUT BIOCHIMIQUE SA |
| Date Received | 2018-04-09 |
| Decision Date | 2018-05-07 |
| PMA | P110005 |
| Supplement | S003 |
| 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 | 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 |