|
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 | S003 |
Date Received | 01/26/2009 |
Decision Date | 02/25/2009 |
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 CHANGE TO SCALE UP THE PRODUCTION OF CELL PASTE USED TO PREPARE PROBES TO REDUCE MANUFACTURING TIME. |