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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.
 
DeviceTOTAL PSA MICROTITER ELISA
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantSiemens Healthcare Diagnostics
333 Coney St.
East Walpole, MA 02032
PMA NumberP950021
Supplement NumberS005
Date Received09/20/2001
Decision Date03/13/2002
Product Code LTJ 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MANUFACTURING SITES LOCATED AT BAYER DIAGNOSTICS, ELKHART, INDIANA AND ONCOGENE SCIENCE, CAMBRIDGE, MASSACHUSETTS.
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