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. |
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Device | ALERE NMP22 TEST |
Generic Name | System, test, tumor marker, for detection of bladder cancer |
Applicant | Abbott Diagnostics Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 |
PMA Number | P940035 |
Supplement Number | S010 |
Date Received | 07/10/2013 |
Decision Date | 07/16/2013 |
Product Code |
NAH |
Advisory Committee |
Immunology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDITIONS TO THE LIMITATIONS AND PRECAUTIONS SECTIONS OF THE PACKAGE INSERT. |
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