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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMATRITECH NMP22 TEST KIT
Classification Namesystem,test,tumor marker,for detection of bladder cancer
Generic Namecarcinoma of urinary tract test kit
ApplicantMATRITECH, INC.
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
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
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