PMA P030052S006
- Device
- UROVYSION BLADDER CANCER KIT
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S006
- Product code
- NSD
- Decision date
- 2011-05-26
- Classification
- Test, Fluorescence In Situ Hybridization (fish), For Bladder Cancer Detection And Monitoring For Recurrence
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- 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.
Current openFDA PMA Record#
- Device
- UROVYSION BLADDER CANCER KIT
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S006
- Product code
- NSD
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Decision date
- 2011-05-26
- Decision code
- APPR
- Date received
- 2011-04-28
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.