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 the removal of the external interstitial thermometry system from the urowave(r).
| Device | DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM |
| Generic Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Applicant | Dornier MedTech America, Inc. |
| Date Received | 1998-06-15 |
| Decision Date | 1998-06-23 |
| PMA | P970044 |
| Supplement | S001 |
| Product Code | MEQ |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Dornier MedTech America, Inc. 1155 Roberts Blvd. kennesaw, GA 30144 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970044 | Original Filing | |
| S003 | 1999-02-02 | Normal 180 Day Track |
| S002 | 1998-06-30 | Real-time Process |
| S001 | 1998-06-15 | Real-time Process |