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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 NumberS014
Date Received08/29/2013
Decision Date09/26/2013
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 A NEW INJECTION SYRINGE (DENOTED AS ¿EZ-FILL SYRINGE¿) FOR HYALGAN® THAT INCORPORATES A TAMPER-EVIDENT CLOSURE SYSTEM CONSISTING OF A SEAL, A TIP CAP, AND A LUER LOCK.
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