PROLIEVE THERMODILATATION SYSTEM
FDA premarket approval P030006/S012 · decided 2006-12-22
Approval details
- PMA number
- P030006
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROLIEVE THERMODILATATION SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Medifocus, Inc.
- Date received
- 2006-11-21
- Decision date
- 2006-12-22
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Columbia, MD
- Statement
- APPROVAL FOR REMOVAL OF A CAPACITOR FROM THE COMPUTER BOARD INPUT LINES TO ENABLE THE TACHOMETER READOUT TO DISPLAY PUMP SPEED AND MODIFICATION OF THE CAPACITORS FROM THE COMPUTER INPUT/OUTPUT BOARD TO DISPLAY OF TEMPERATURE DATA.
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