- Device
- UROWAVE
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P970044
- Supplement
- S003
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 1999-03-12
- Decision code
- APPR
- Date received
- 1999-02-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Dornier Medizintechnik GmbH, Argeisrieder Feld 7, D-82234 Wessling, Germany.