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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.
 
DeviceIMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
GLYN RHONWY, LLANBERIS
GWYNEDD LL55 4EL LL554
PMA NumberP930027
Supplement NumberS004
Date Received01/02/2001
Decision Date06/19/2001
Product Code LTJ 
Docket Number 01M-0535
Notice Date 12/05/2001
Advisory Committee Immunology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
IMMULITE PSA, IMMULITE. THIRD GENERATION PSA, IMMULITE 2000 PSA, AND IMMULITE 2000 THIRD GENERATION PSA. IMMULITE. PSA IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM, 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. IMMULITE THIRD GENERATION PSA IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM, 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. IMMULITE 2000 PSA IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2000 ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM, 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. IMMULITE 2000 THIRD GENERATION PSA IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2000 ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM, AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) IN MEN AGED 50 YEARS OF OLDER.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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