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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.
 
DeviceSYNVISC HYLAN G-F 20
Classification Nameacid, hyaluronic, intraarticular
Generic Nameacid, hyaluronic, intraarticular
Applicant
GENZYME CORP.
55 cambridge parkway
4th floor
cambridge, MA 02142
PMA NumberP940015
Supplement NumberS010
Date Received08/15/2003
Decision Date09/12/2003
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the patient package insert for synvisc that are intended to strengthen the information for patients by increasing the type size, decreasing the reading level, more fully describing the u. S. Clinical trial, describing the signs of an allergic reaction, and by making other revisions to the insert.
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