DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM
FDA premarket approval P970044/S002 · decided 1998-07-10
Approval details
- PMA number
- P970044
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Dornier Medtech America, Inc.
- Date received
- 1998-06-30
- Decision date
- 1998-07-10
- Days to decision
- 10 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- Approval for a mobile/transportable Urowave(R).
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