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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.
 
DeviceNMP22 BLADDERCHEK TEST
Generic NameSystem, test, tumor marker, for detection of bladder cancer
ApplicantAbbott Diagnostics Scarborough, Inc.
10 Southgate Road
Scarborough, ME 04074
PMA NumberP940035
Supplement NumberS009
Date Received03/18/2013
Decision Date04/02/2013
Product Code NAH 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
INCREASE THE MANUFACTURING EFFICIENCY OF THE ASSEMBLED CASSETTE BY MODIFYING THE ASSEMBLY METHOD USED IN THE MANUFACTURE OF NMP22 BLADDERCHEK FROM ASSEMBLED AND POUCHED MANUALLY BY HAND BY OPERATORS, TO BE ASSEMBLED BY VALIDATED AUTOMATED EQUIPMENT.
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