PMA P970008S003

Device
UROLOGIC TARGIS SYSTEM
Applicant
Urologix, LLC
PMA number
P970008
Supplement
S003
Product code
MEQ
Decision date
1997-10-28
Classification
System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement
Approval for the addition of a capacitor to the circuitry leading to each of the five sensors withing the rectal thermosensing unit (RTU) of the Targis(TM) System to improve the accuracy of the RTU temperature readings.

Current openFDA PMA Record#

Device
UROLOGIC TARGIS SYSTEM
Applicant
Urologix, LLC
PMA number
P970008
Supplement
S003
Product code
MEQ
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date
1997-10-28
Decision code
APPR
Date received
1997-10-22
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the addition of a capacitor to the circuitry leading to each of the five sensors withing the rectal thermosensing unit (RTU) of the Targis(TM) System to improve the accuracy of the RTU temperature readings.