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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
Generic NameAcid, hyaluronic, intraarticular
ApplicantFIDIA FARMACEUTICI
PONTE DELLA FABBRICA 3/A
ABANO TERME 35031
PMA NumberP150010
Supplement NumberS001
Date Received10/24/2016
Decision Date11/22/2016
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Manufacturing process change to preparation of the principal bulk component.
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