UROLOGIX PROSTATRON SYSTEM
FDA premarket approval P950014/S025 · decided 2005-05-25
Approval details
- PMA number
- P950014
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UROLOGIX PROSTATRON SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, Inc.
- Date received
- 2005-04-14
- Decision date
- 2005-05-25
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL TO MODIFY A VOLTAGE TOLERANCE SETTING AND TO REPLACE THE CURRENT SOFTWARE WITH ITS PREVIOUSLY APPROVED VERSION.
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