UROVYSION BLADDER CANCER KIT ASSAY
FDA premarket approval P030052/S007 · decided 2011-06-01
Approval details
- PMA number
- P030052
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UROVYSION BLADDER CANCER KIT ASSAY
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Applicant
- Abbott Molecular
- Date received
- 2011-05-06
- Decision date
- 2011-06-01
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NSD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- IMPLEMENTATION OF PROCESS CHANGE TO THE MANUFACTURE OF THE FISH DNA BULK PROBE SOLUTION, INCLUDING A NEW FISH DNA EXTRACTION PROCESS, A NEW SONICATION EQUIPMENT, A NEW AMINATION/LABELING PROCEDURE, AND A SUPPLEMENTAL DNA PURIFICATION PROCESSING STEP TO REDUCE RNA CARRY-OVER.
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