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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.
Classification Namesystem,test,tumor marker,for detection of bladder cancer
Generic Namesystem,test,tumor marker,for detection of bladder cancer
10 southgate road
scarborough, ME 04074
PMA NumberP940035
Supplement NumberS002
Date Received07/23/1999
Decision Date01/18/2000
Product Code
NAH[ Registered Establishments with NAH ]
Docket Number 00M-1522
Notice Date 09/21/2000
Advisory Committee Immunology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The device is used as an aid 1)in the diagnosis of persons with symptoms or risk factors for transitional cell cancer (TCC) of the bladder (cut-off >= 7.5U/ml) in conjunction with and not in lieu of current standard diagnostic procedures and 2) in the management of patients with transitional cell carcinoma of the bladder, after surgical treatment to identify those patients with occult or rapidly recurring TCC (cut-off >10U/ml).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling