PMA supplement
P840015 S006: CLINI-THERM MARK I/IV
FDA PMA supplement · Normal 180 Day Track · Clini-Therm Corp.
Key facts
| Original PMA | P840015 |
|---|---|
| Supplement number | S006 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | CLINI-THERM MARK I/IV |
| Generic name | System, rf/microwave hyperthermia, cancer treatment |
| Applicant | Clini-Therm Corp. |
| Product code | LOC |
| Received date | Aug 26, 1987 |
| Decision date | Jan 21, 1988 |
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: