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 revisions to the labeling of gelsyn-3 as follows: 1) deletion of the statement, the safety and effectiveness of repeat treatment cycles of gel-syn have not been established from the patient information leaflet and addition of the statement, the effectiveness of repeat treatment cycles of gelsyn-3 has not been established. To the product information and patient information leaflets; and2) addition of the statements, adverse experience data from clinical use does not show an increased safety risk from retreatment with gelsyn-3. The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle to the product information and patient information leaflets.
| Device | GELSYN-3 |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | IBSA INSTITUT BIOCHIMIQUE SA |
| Date Received | 2017-01-19 |
| Decision Date | 2017-03-10 |
| PMA | P110005 |
| Supplement | S002 |
| 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 | 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 |