UroVysion Bladder Cancer Kit
FDA premarket approval P030052/S024 · decided 2018-08-29
Approval details
- PMA number
- P030052
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UroVysion Bladder Cancer Kit
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Applicant
- Abbott Molecular
- Date received
- 2018-08-10
- Decision date
- 2018-08-29
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- NSD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- QC/manufacturing equipment changes and DNA Ladder changes.
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