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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 NumberS004
Date Received05/08/2020
Decision Date06/07/2020
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for revision of the instructions for administration of GenVisc 850 to help prevent any leakage of the product during administration.
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