RECTAL THERMOSENSING UNIT RTU
FDA premarket approval P970008/S009 · decided 1998-10-29
Approval details
- PMA number
- P970008
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RECTAL THERMOSENSING UNIT RTU
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 1998-10-21
- Decision date
- 1998-10-29
- Days to decision
- 8 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for minor changes in the design and labeling of the Rectal Thermosensing Unit.
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