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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.
 
DeviceTriVisc®
Generic NameAcid, hyaluronic, intraarticular
ApplicantChannel-Markers Medical, LLC
8801 Fast Park Dr. Suite 301
Raleigh, NC 27617
PMA NumberP160057
Supplement NumberS002
Date Received05/02/2023
Decision Date06/22/2023
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  
Moving the manufacturing and sterilization site of the glass syringes (i.e., barrels) from BD Columbus, USA to BD Cuautitlán, Mexico.
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