PMA P030006S019

Device
PROLIEVE THERMODILITATION SYSTEM
Applicant
Medifocus, Inc.
PMA number
P030006
Supplement
S019
Product code
MEQ
Decision date
2008-08-13
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement
APPROVAL FOR MODIFICATION AND REPLACEMENT OF THE THERMOELECTRIC CONTROLLER BOARD.

Current openFDA PMA Record#

Device
PROLIEVE THERMODILITATION SYSTEM
Applicant
Medifocus, Inc.
PMA number
P030006
Supplement
S019
Product code
MEQ
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date
2008-08-13
Decision code
APPR
Date received
2008-07-01
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR MODIFICATION AND REPLACEMENT OF THE THERMOELECTRIC CONTROLLER BOARD.