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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.
 
DeviceHYALGAN
Generic NameAcid, hyaluronic, intraarticular
ApplicantFIDIA FARMACEUTICI SPA
VIA PONTE DELLA FABBRICA 3/A
ABANO TERME, PADUA (PD) 35031
PMA NumberP950027
Supplement NumberS015
Date Received08/01/2016
Decision Date08/26/2016
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  
Change in the filter cartridge used during manufacturing of Hyalgan.
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