PMA supplement
P030052 S017: UROVYSION BLADDER CANCER KIT,PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT
FDA PMA supplement · 135 Review Track For 30-Day Notice · Abbott Molecular
Key facts
| Original PMA | P030052 |
|---|---|
| Supplement number | S017 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | UROVYSION BLADDER CANCER KIT,PROBECHEK CONTROL SLIDES FOR 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 | Nov 12, 2015 |
| Decision date | Dec 29, 2015 |
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: