PMA supplement
P000043 S015: TMX-2000 THERMATRX OFFICE THERMO THERAPY SYSTEM
FDA PMA supplement · Normal 180 Day Track No User Fee · Boston Scientific Corp
Key facts
| Original PMA | P000043 |
|---|---|
| Supplement number | S015 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | TMX-2000 THERMATRX OFFICE THERMO THERAPY SYSTEM |
| Generic name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
| Applicant | Boston Scientific Corp |
| Product code | MEQ |
| Received date | Jul 19, 2006 |
| Decision date | Dec 15, 2006 |
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: