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 | URO VYSION BLADDER CANCER KIT |
Generic Name | Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence |
Applicant | ABBOTT MOLECULAR 1300 E. Touhy Avenue Des Plaines, IL 60018 |
PMA Number | P030052 |
Supplement Number | S013 |
Date Received | 11/05/2013 |
Decision Date | 11/27/2013 |
Product Code |
NSD |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGING THE CONFIGURATION OF THEIR CURRENT LABEL PRINTER, LABEL PRINTING SOFTWARE,AND LABEL INSPECTION SYSTEM FOR THE FOLLOWING FISH ASSAYS: VYSIS ALK BREAK APART FISH PROBE KIT, UROVYSION BLADDER CANCER KIT, AND PATHVYSION HER-2DNA PROBE KIT. |
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