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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.
 
DeviceSUPARTZ
Generic NameAcid, hyaluronic, intraarticular
ApplicantSEIKAGAKU CORP.
6-1, MARUNOUCHI 1-CHOME,
CHIYODA-KU
TOKYO 100-0-0005
PMA NumberP980044
Supplement NumberS006
Date Received01/30/2007
Decision Date03/07/2007
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 ADDING BOTH POSSIBLE ADVERSE REACTIONS REPORTED WORLDWIDE TO THE INSTRUCTION FOR USE, AND THE POSSIBLE SIDE EFFECTS COLLECTED FROM WORLDWIDE POST-MARKET EXPERIENCE TO THE PATIENT INFORMATION BROCHURE.
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