PMA supplement
P000043 S002: TMX-2000 (TM) BPH THERMOTHERAPY SYSTEM
FDA PMA supplement · Real-Time Process · Boston Scientific Corp
Key facts
| Original PMA | P000043 |
|---|---|
| Supplement number | S002 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | TMX-2000 (TM) BPH THERMOTHERAPY SYSTEM |
| Generic name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
| Applicant | Boston Scientific Corp |
| Product code | MEQ |
| Received date | Dec 20, 2001 |
| Decision date | Jan 11, 2002 |
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: