| 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. |
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| Trade Name | MATRITECH NMP22 TEST KIT |
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| Classification Name | system,test,tumor marker,for detection of bladder cancer |
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| Generic Name | carcinoma of urinary tract test kit |
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| Applicant | MATRITECH, INC. |
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| PMA Number | P940035 |
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| Supplement Number | S002 |
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| Date Received | 07/23/1999 |
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| Decision Date | 01/18/2000 |
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| Product Code | |
| Docket Number | 00M-1522 |
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| Notice Date | 09/21/2000 |
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| Advisory Committee |
Immunology |
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| Supplement Type | panel track |
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| Supplement Reason | labeling change - indications |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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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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