This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for changes to the computer system and revisions to the operator's manual for the sonotherm 1000.
| Device | SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM |
| Classification Name | Applicator, Hyperthermia, Deep Heating, Ultrasound |
| Generic Name | Applicator, Hyperthermia, Deep Heating, Ultrasound |
| Applicant | LABTHERMICS TECHNOLOGIES, INC. |
| Date Received | 1996-12-16 |
| Decision Date | 1997-02-13 |
| PMA | P880062 |
| Supplement | S002 |
| Product Code | LNB |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LABTHERMICS TECHNOLOGIES, INC. 701 Devonshire Dr., Bldg. B-1 champaign, IL 61820 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880062 | Original Filing | |
| S002 | 1996-12-16 | Normal 180 Day Track |
| S001 | 1990-05-17 | Normal 180 Day Track |