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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.
 
DeviceGenVisc 850
Generic NameAcid, hyaluronic, intraarticular
ApplicantChannel-Markers Medical, LLC
8801 Fast Park Dr. Suite 301
Raleigh, NC 27617
PMA NumberP140005
Supplement NumberS006
Date Received05/05/2025
Decision Date05/20/2025
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of an alternate supplier of bulk sodium hyaluronate (HA) raw material for GenVisc 850 and Trivisc
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