PMA P030052S004
- Device
- UROVYSION BLADDER CANCER KIT
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S004
- Product code
- NSD
- Decision date
- 2011-03-22
- 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 TO PROVIDE THE DEFINITION FOR THE PEPSIN ACTIVITY OF THE VYSIS PROTEASE REAGENT IN THE UROVYSION PACKAGE INSERT.
Current openFDA PMA Record#
- Device
- UROVYSION BLADDER CANCER KIT
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S004
- Product code
- NSD
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Decision date
- 2011-03-22
- Decision code
- APPR
- Date received
- 2011-02-25
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO PROVIDE THE DEFINITION FOR THE PEPSIN ACTIVITY OF THE VYSIS PROTEASE REAGENT IN THE UROVYSION PACKAGE INSERT.