PMA supplement
P970008 S050: UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
FDA PMA supplement · 30-Day Notice · Urologix, LLC
Key facts
| Original PMA | P970008 |
|---|---|
| Supplement number | S050 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH |
| Generic name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
| Applicant | Urologix, LLC |
| Product code | MEQ |
| Received date | Mar 19, 2010 |
| Decision date | Apr 15, 2010 |
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: