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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.
 
DeviceDimension Vista TPSA Flex reagent cartridge (K6451)
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
ApplicantSiemens Healthcare Diagnostics
500 Gbc Dr.
P.O. Box 6101
Newark, DE 19714
PMA NumberP000021
Supplement NumberS041
Date Received06/19/2019
Decision Date06/26/2019
Product Codes MTF LTJ 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Add an alternate supplier to manufacture resin used in the production of Dimension Vista® Chemibead and Sensibead reagents.
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