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Device | UROVYSION 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 | S006 |
Date Received | 04/28/2011 |
Decision Date | 05/26/2011 |
Product Code |
NSD |
Advisory Committee |
Pathology |
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 A LABELING CHANGE TO THE UROVYSION BLADDER CANCER KIT PACKAGE INSERT TO CORRECT AN INACCURACY IN A LABELING SCHEMATIC IN THE UROVYSION PACKAGE INSERT 30-608358 IDENTIFIED DURING A REVIEW OF THE PACKAGE INSERT. |