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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 BIOSURGERY
PMA NumberP940015
Supplement NumberS007
Date Received03/29/2002
Decision Date04/26/2002
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Physical Medicine
Supplement Type Special Supplement
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the following statement to the synvisc physician package insert: "precaution: do not over tighten or apply excessive leverage when attaching the needle or removing the needle guard, as this may break the tip of the syringe. ".
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