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. |
|
Device | NMP22 BLADDERCHEK 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 | S009 |
Date Received | 03/18/2013 |
Decision Date | 04/02/2013 |
Product Code |
NAH |
Advisory Committee |
Immunology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement INCREASE THE MANUFACTURING EFFICIENCY OF THE ASSEMBLED CASSETTE BY MODIFYING THE ASSEMBLY METHOD USED IN THE MANUFACTURE OF NMP22 BLADDERCHEK FROM ASSEMBLED AND POUCHED MANUALLY BY HAND BY OPERATORS, TO BE ASSEMBLED BY VALIDATED AUTOMATED EQUIPMENT. |
|
|