|
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 | S002 |
Date Received | 01/08/2007 |
Decision Date | 02/06/2007 |
Product Code |
NSD |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE THERMOBRITE AUTOMATED SLIDE HEATING PLATE SUPPLIED BY AN ALTERNATE VENDOR AS AN OPTIONAL ALTERNATIVE OF THE HYBRITE AUTOMATED SLIDE HEATING PLATE INSTRUMENT AND TO ADD INSTRUCTIONS FOR USE OF SAID THERMOBRITE TO THE CURRENT UROVYSION BLADDER CANCER KIT PACKAGE INSERT. |