PMA P970008S049

Device
UROLOGIX TARGIS SYSTEM
Applicant
Urologix, LLC
PMA number
P970008
Supplement
S049
Product code
MEQ
Decision date
2010-05-13
Classification
System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement
APPROVAL TO REPLACE AN OBSOLETE TOUCHSCREEN AND MODIFY THE MICROWAVE GENERATOR TO IMPROVE DESIGN MARGINS.

Current openFDA PMA Record#

Device
UROLOGIX TARGIS SYSTEM
Applicant
Urologix, LLC
PMA number
P970008
Supplement
S049
Product code
MEQ
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date
2010-05-13
Decision code
APPR
Date received
2010-03-17
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL TO REPLACE AN OBSOLETE TOUCHSCREEN AND MODIFY THE MICROWAVE GENERATOR TO IMPROVE DESIGN MARGINS.