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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.
 
DeviceADVIA IMS PROSTATE SPECIFIC ANTIGEN ASSAY (PSA)
Classification Nameantigen(complexed),prostate specific,(cpsa)
Generic Nameantigen(complexed),prostate specific,(cpsa)
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
333 coney street
walpole, MA 02032-1516
PMA NumberP990055
Supplement NumberS009
Date Received05/17/2006
Decision Date11/06/2006
Product Code
NAF[ Registered Establishments with NAF ]
Advisory Committee Immunology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE CHANGE LOCATED AT FISHER DIAGNOSTICS, MIDDLETOWN, VIRGINIA.
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