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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
Classification Nameacid, hyaluronic, intraarticular
Generic Nameacid, hyaluronic, intraarticular
Applicant
SEIKAGAKU CORP.
6-1, marunouchi 1-chome,
chiyoda-ku
tokyo 100-0-0005
PMA NumberP980044
Supplement NumberS015
Date Received06/12/2013
Decision Date07/12/2013
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
SHARING OF MANUFACTURING EQUIPMENT FOR USE WITH AN INVESTIGATIONAL PRODUCT.
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