PMA
P030052: UROVYSION BLADDER CANCER KIT
FDA PMA · Abbott Molecular
Key facts
| PMA number | P030052 |
|---|---|
| Trade name | UROVYSION BLADDER CANCER KIT |
| Applicant | Abbott Molecular |
| Owner/operator | ABBOTT LABORATORIES |
| Approval date | Jan 24, 2005 |
| Docket number | 05M-0130 |
| Notice date | Apr 12, 2005 |
| Establishment registration | 3005248192 |
| FEI number | 3005248192 |
At a glance
- 10–99 Supplements
- Feb 18, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: