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 | GELSYN-3 |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | IBSA INSTITUT BIOCHIMIQUE SAvia Al Ponte 13, Ch-6903lugano Ticino 6903 PMA NumberP110005 Supplement NumberS012 Date Received09/08/2022 Decision Date10/07/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-09-08 |
| Decision Date | 2022-10-07 |
| PMA | P110005 |
| Supplement | S012 |
| 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 PMA NumberP110005 Supplement NumberS012 Date Received09/08/2022 Decision Date10/07/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Revisions To The Adverse Reactions Section Of The Product Information And Patient Information Labeling Based On Post-market Adverse Event And Safety Data Collected Up To March 2022. |
| 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 |