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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 NameSYNVISC (HYLAN G-F 20)
Classification Nameacid, hyaluronic, intraarticular
ApplicantGENZYME CORP.
PMA NumberP940015
Supplement NumberS009
Date Received02/14/2003
Decision Date03/14/2003
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Physical Medicine
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the following precaution statement to the synvisc physician package insert: "twist the gray tip cap before pulling it off, as this will minimize product leakage".
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