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 a design change to enhance the heat focusing capabilities of the microfocus 1000 hyperthermia system.
| Device | HYPERTHERMIA SYSTEM 100 A |
| Classification Name | Applicator, Hyperthermia, Superficial, Rf/microwave |
| Generic Name | Applicator, Hyperthermia, Superficial, Rf/microwave |
| Applicant | MEDIFOCUS, INC |
| Date Received | 1997-07-15 |
| Decision Date | 1997-09-17 |
| PMA | P880064 |
| Supplement | S002 |
| Product Code | LNC |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDIFOCUS, INC 10240 Old Columbia Road suite G columbia, MD 21046 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880064 | Original Filing | |
| S002 | 1997-07-15 | Normal 180 Day Track |
| S001 |