DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM
FDA premarket approval P970044 · decided 1998-05-29
Approval details
- PMA number
- P970044
- Trade name
- 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
- Days to decision
- 263 days
- Decision code
- APWD
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Kennesaw, GA
- 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.
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