Premarket Approval (PMA)

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: 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 Ave.; Des Plaines, IL 60018
• PMA Number: P030052
• Supplement Number: S024
• Date Received: 08/10/2018
• Decision Date: 08/29/2018
• 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
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
QC/manufacturing equipment changes and DNA Ladder changes.