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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.
 
DeviceHYMOVIS ONE
Generic NameAcid, hyaluronic, intraarticular
ApplicantFIDIA FARMACEUTICI
PONTE DELLA FABBRICA 3/A
ABANO TERME 35031
PMA NumberP150010
Supplement NumberS005
Date Received12/23/2024
Decision Date04/09/2025
Product Code MOZ 
Docket Number 25M-1101
Notice Date 04/21/2025
Advisory Committee Orthopedic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
HYMOVIS® ONE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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