This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
This device is indicated as a non-surgical treatment alternative to transurethral resection of the prostate (turp) for the treatment of symptomatic benign prostatic hyperplasia (bph) in men with prostatic lengths between 30 mm and 55 mm.
| Device | DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM |
| Generic Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Applicant | Dornier MedTech America, Inc. |
| Date Received | 1997-09-08 |
| Decision Date | 1998-05-29 |
| Notice Date | 1998-06-23 |
| PMA | P970044 |
| Supplement | S |
| Product Code | MEQ |
| Docket Number | 98M-0403 |
| Advisory Committee | Gastroenterology/Urology |
| 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 |