UROVYSION BLADDER CANCER KIT
FDA premarket approval P030052/S006 · decided 2011-05-26
Approval details
- PMA number
- P030052
- Supplement
- S006
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2011-04-28
- Decision date
- 2011-05-26
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NSD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- 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.
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