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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.
 
DeviceGELSYN-3
Generic Nameacid, hyaluronic, intraarticular
ApplicantIBSA INSTITUT BIOCHIMIQUE SA
via al ponte 13, ch-6903
lugano ticino 6903
PMA NumberP110005
Supplement NumberS003
Date Received04/09/2018
Decision Date05/07/2018
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 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.
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