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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.
 
DeviceCIBA CORNING ACS PSA IMMUNOASSAY
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantBayer Healthcare, LLC
511 Benedict Ave.
Tarrytown, NY 10591
PMA NumberP920030
Supplement NumberS001
Date Received09/14/1995
Decision Date12/13/1995
Withdrawal Date01/08/2003
Product Code LTJ 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE METHOD OF STANDARDIZATION OF THE CALIBRATORS FOR THE ASSAY
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