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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 S.P.A.
Via Ponte Della Fabbrica 3/A
Abano Terme 35031
PMA NumberP950027
Supplement NumberS006
Date Received01/07/2005
Decision Date07/19/2005
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFYING THE SPECIFICATIONS FOR THE ACTIVE INGREDIENT (SODIUM HYALURONATE) BY ELIMINATING THE ABNORMAL TOXICITY TEST AND REPLACING THE RABBIT PYROGEN TEST WITH THE BACTERIAL ENDOTOXINS TEST (LIMULUS AMOEBOCYTE LYSATE (LAL) TEST) AND MODIFYING THE SPECIFICATIONS FOR THE FINISHED PRODUCT TO REPLACE THE RABBIT PYROGEN TEST WITH THE LAL TEST.
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