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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHYALGAN
Classification Nameacid, hyaluronic, intraarticular
Generic Namesodium hyaluronate
ApplicantFIDIA FARMACEUTICI
PMA NumberP950027
Supplement NumberS014
Date Received08/29/2013
Decision Date09/26/2013
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
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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