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.
|Classification Name||Acid, Hyaluronic, Intraarticular|
|Generic Name||Acid, Hyaluronic, Intraarticular|
|Applicant||IBSA INSTITUT BIOCHIMIQUE SA|
|Supplement Type||Normal 180 Day Track|
|Supplement Reason||Labeling Change - Indications/instructions/shelf Life/tradename|
|Applicant Address||IBSA INSTITUT BIOCHIMIQUE SA via Al Ponte 13, Ch-6903 lugano Ticino 6903|
|Supplement Number||Date||Supplement Type|
|S009||2021-03-31||135 Review Track For 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|