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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
ApplicantBIOMATRIX, INC.
PMA NumberP940015
Supplement NumberS004
Date Received05/03/1999
Decision Date05/26/1999
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 labeling changes to the physician package insert. The device, as modified, will be marketed under the trade name synvisc(r) (hylan g-f 20) and is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e. G. , acetaminophen.
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