Note: 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. |
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Device | DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM |
Generic Name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
Applicant | Dornier MedTech America, Inc. 1155 ROBERTS BLVD. KENNESAW, GA 30144 |
PMA Number | P970044 |
Date Received | 09/08/1997 |
Decision Date | 05/29/1998 |
Withdrawal Date
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07/23/2002 |
Product Code |
MEQ |
Docket Number | 98M-0403 |
Notice Date | 06/23/1998 |
Advisory Committee |
Gastroenterology/Urology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |
Supplements: |
S001 S002 S003 |
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