UROVYSION BLADDER CANCER KIT
FDA premarket approval P030052/S004 · decided 2011-03-22
Approval details
- PMA number
- P030052
- Supplement
- S004
- 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
- 2011-02-25
- Decision date
- 2011-03-22
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- NSD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- APPROVAL TO PROVIDE THE DEFINITION FOR THE PEPSIN ACTIVITY OF THE VYSIS PROTEASE REAGENT IN THE UROVYSION PACKAGE INSERT.
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