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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(R)
Generic NameAcid, hyaluronic, intraarticular
ApplicantFidia Farmaceutici S.P.A.
Via Ponte Della Fabbrica 3/A
Abano Terme 35031
PMA NumberP950027
Supplement NumberS001
Date Received06/24/1997
Decision Date07/08/1997
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE U.S. DISTRIBUTOR, SANOFI PHARMACEUTICALS, INC., NEW YORK, NEW YORK. ADDITIONALLY, WE HAVE REVIEWED THE EDITORIAL CHANGES YOU PROPOSE FOR THE LABELING FOR YOUR PRODUCT AND HAVE DETERMINED THAT THEY ARE APPROPRIATE.
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