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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 Systems PSA, IMMULITE 2000 Systems PSA & IMMULITE Systems Third Generation PSA
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantSiemens Healthcare Diagnostics, Inc.
Glyn Rhonwy, Llanberis
Gwynedd Ll55 4el LL554EL
PMA NumberP930027
Supplement NumberS021
Date Received06/19/2019
Decision Date07/11/2019
Product Code MTF 
Advisory Committee Immunology
Supplement TypeSpecial (Immediate 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 a change to the product quality control (QC) method in order to enhance the safety of IMMULITE® Third Generation PSA High Adjustor (LUPH), IMMULITE® Systems PSA High Adjustor (LPSH) and IMMULITE® 2000 Systems PSA High Adjustor (LPSH)
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