PMA P030006S012

Device: PROLIEVE THERMODILATATION SYSTEM
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S012
Product code: MEQ
Decision date: 2006-12-22
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order 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.

Current openFDA PMA Record#

Device: PROLIEVE THERMODILATATION SYSTEM
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S012
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 2006-12-22
Decision code: APPR
Date received: 2006-11-21
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.