PMA
P880062: SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM
FDA PMA · Applicator, hyperthermia, deep heating, ultrasound · Labthermics Technologies, Inc.
Key facts
| PMA number | P880062 |
|---|---|
| Trade name | SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM |
| Generic name | Applicator, hyperthermia, deep heating, ultrasound |
| Applicant | Labthermics Technologies, Inc. |
| Product code | LNB |
| Approval date | Sep 29, 1989 |
| Docket number | 89M-0449 |
| Notice date | Nov 14, 1989 |
| FEI number | 1450048 |
At a glance
- 1–9 Supplements
- Feb 13, 1997 Latest supplement decision
- No Withdrawn
- No 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: