PROLIEVE THERMODILITATION SYSTEM
FDA premarket approval P030006/S017 · decided 2009-05-18
Approval details
- PMA number
- P030006
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROLIEVE THERMODILITATION SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Medifocus, Inc.
- Date received
- 2008-02-12
- Decision date
- 2009-05-18
- Days to decision
- 461 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Columbia, MD
- Statement
- APPROVAL FOR A RECTAL TEMPERATURE MONITOR WHICH IS DISPOSABLE. THE DISPOSABLE RECTAL TEMPERATURE MONITOR WILL BE CONTRACT MANUFACTURED AT PHILLIPS PLASTIC CORPORATION, SHORT-RUN FACILITY (PHILLIPS SHORT-RUN) LOCATED IN RICHMOND, WISCONSIN.
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