PMA P030052
- Device
- UroVysion Bladder Cancer Kit
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S028
- Product code
- NSD
- Decision date
- 2026-02-18
- Generic name
- Test, Fluorescence In Situ Hybridization (fish), For Bladder Cancer Detection And Monitoring For Recurrence
- Approval order statement
- implementation of a secondary packaging process
Current openFDA PMA Record#
- Device
- UroVysion Bladder Cancer Kit
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S030
- Decision date
- 2026-02-18
- Decision code
- OK30
- Date received
- 2026-01-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of a secondary packaging process