PMA
P030006: PROLIEVE THERMODILATATION SYSTEM
FDA PMA · System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy · Medifocus, Inc.
Key facts
| PMA number | P030006 |
|---|---|
| Trade name | PROLIEVE THERMODILATATION SYSTEM |
| Generic name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
| Applicant | Medifocus, Inc. |
| Owner/operator | Medifocus Inc |
| Product code | MEQ |
| Approval date | Feb 19, 2004 |
| Docket number | 04M-0116 |
| Notice date | Mar 9, 2004 |
| Establishment registration | 3009969279 |
| FEI number | 3009969279 |
At a glance
- 10–99 Supplements
- Nov 21, 2018 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- No Withdrawn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: