PMA supplement
P030052 S010: UROVYSION BLADDER CANCER KIT
FDA PMA supplement · Special (Immediate Track) · Abbott Molecular
Key facts
| Original PMA | P030052 |
|---|---|
| Supplement number | S010 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | 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 |
| Product code | NSD |
| Received date | Oct 25, 2012 |
| Decision date | Nov 13, 2012 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: