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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 FPSA Flex Reagent Cartidge
Generic Nametest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
500 gbc drive, p o box 6101
m/s 514
newark, DE 19714-6101
PMA NumberP020027
Supplement NumberS032
Date Received04/17/2018
Decision Date05/14/2018
Product Code MTG 
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Add an alternate Surlyn 1601-2 resin to manufacture Surlyn™ Film used in the production of Dimension® Cuvette Canister Consumable.