PMA
P000043: TMX-2000 BPH THERMOTHERAPY SYSTEM
FDA PMA · System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy · Boston Scientific Corp
Key facts
| PMA number | P000043 |
|---|---|
| Trade name | TMX-2000 BPH THERMOTHERAPY SYSTEM |
| Generic name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | MEQ |
| Approval date | Jun 29, 2001 |
| Docket number | 01M-0296 |
| Notice date | Jul 16, 2001 |
| Establishment registration | 3005099803 |
| FEI number | 3005099803 |
At a glance
- 10–99 Supplements
- Sep 18, 2013 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: