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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSYNVISC(HYLAN G-F 20)
Generic NameAcid, hyaluronic, intraarticular
ApplicantSanofi GENZYME CORP.
50 Binney Street
Cambridge, MA 02142
PMA NumberP940015
Supplement NumberS007
Date Received03/29/2002
Decision Date04/26/2002
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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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