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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 NumberS002
Date Received04/20/1998
Decision Date12/08/1998
Withdrawal Date 01/08/2003
Product Code LTJ 
Docket Number 00M-1536
Notice Date 09/27/2000
Advisory Committee Immunology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of a new indication for use. The device, as modified, will be marketed under the trade names ACS:180 PSA2 assay and ACS:Centaur PSA2 assay and is indicated for the following indications for use: as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. Prostatic biopsy is required for the diagnosis of cancer; and as aid in the management of patients with prostate cancer.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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