PMA P030006S020

Device
PROLIEVE THERMODILITATION SYSTEM
Applicant
Medifocus, Inc.
PMA number
P030006
Supplement
S020
Product code
MEQ
Decision date
2008-12-09
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement
ADDITION OF AN ADHESIVE IN THE MANUFACTURING OF THE RECTAL TEMPERATURE MONITOR.

Current openFDA PMA Record#

Device
PROLIEVE THERMODILITATION SYSTEM
Applicant
Medifocus, Inc.
PMA number
P030006
Supplement
S020
Product code
MEQ
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date
2008-12-09
Decision code
OK30
Date received
2008-11-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF AN ADHESIVE IN THE MANUFACTURING OF THE RECTAL TEMPERATURE MONITOR.