UROWAVE
FDA premarket approval P970044/S003 · decided 1999-03-12
Approval details
- PMA number
- P970044
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- 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
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- Approval for a manufacturing site located at Dornier Medizintechnik GmbH, Argeisrieder Feld 7, D-82234 Wessling, Germany.
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