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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.
 
DeviceALERE NMP22 TEST
Generic NameSystem, test, tumor marker, for detection of bladder cancer
ApplicantAbbott Diagnostics Scarborough, Inc.
10 Southgate Road
Scarborough, ME 04074
PMA NumberP940035
Supplement NumberS010
Date Received07/10/2013
Decision Date07/16/2013
Product Code NAH 
Advisory Committee Immunology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDITIONS TO THE LIMITATIONS AND PRECAUTIONS SECTIONS OF THE PACKAGE INSERT.
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