CLINI-THERM MARK I/IV
FDA premarket approval P840015/S008 · decided 1988-02-19
Approval details
- PMA number
- P840015
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLINI-THERM MARK I/IV
- Generic name
- System, rf/microwave hyperthermia, cancer treatment
- Applicant
- Clini-Therm Corp.
- Date received
- 1987-09-02
- Decision date
- 1988-02-19
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- LOC
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Dallas, TX
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| THERMO SENTRY 1200 THERMO-SYS-TS1200 (K833711) | Clini-Therm Corp. | 1984-04-13 |