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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: 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.
Generic Nameacid, hyaluronic, intraarticular
via al ponte 13, ch-6903
lugano ticino 6903
PMA NumberP110005
Supplement NumberS002
Date Received01/19/2017
Decision Date03/10/2017
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
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.