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 manufacturing site located at dornier medizintechnik gmbh, argeisrieder feld 7, d-82234 wessling, germany.
| Device | UROWAVE |
| Generic Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Applicant | Dornier MedTech America, Inc. |
| Date Received | 1999-02-02 |
| Decision Date | 1999-03-12 |
| PMA | P970044 |
| Supplement | S003 |
| Product Code | MEQ |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |