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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.
 
DeviceAIA-PACK PA
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantTOSOH BIOSCIENCE, INC.
6000 SHORELINE COURT
SUITE 101
SOUTH SAN FRANCISCO, CA 94080
PMA NumberP910065
Supplement NumberS003
Date Received01/09/2002
Decision Date09/09/2002
Product Code LTJ 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO CHANGE THE LOCATION OF THE MANUFACTURING FACILITY OF THE ASCITES FLUID USED IN THE PREPARATION OF THE MONOCLONAL ANTIBODIES FROM THE TOSOH TOKYO RESEARCH CENTER IN AYASE, JAPAN TO NISSEIKEN, CO. LTD. IN TOKYO, JAPAN.
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