PMA
P840015: CLINI-THERM MARK I/IV
FDA PMA · System, rf/microwave hyperthermia, cancer treatment · Clini-Therm Corp.
Key facts
| PMA number | P840015 |
|---|---|
| Trade name | CLINI-THERM MARK I/IV |
| Generic name | System, rf/microwave hyperthermia, cancer treatment |
| Applicant | Clini-Therm Corp. |
| Product code | LOC |
| Approval date | Aug 16, 1985 |
| Docket number | 85M-0416 |
| Notice date | Sep 11, 1985 |
At a glance
- 10–99 Supplements
- Jul 17, 1990 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- No Withdrawn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: