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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 NumberS003
Date Received08/24/1998
Decision Date12/18/1999
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modification of labeling and additional information about the current clinical experience of the device as detailed in amendment received 12/10/99.
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