PMA P970008S011

Device
UROLOGIX TARGIS SYSTEM
Applicant
Urologix, LLC
PMA number
P970008
Supplement
S011
Product code
MEQ
Decision date
1999-05-03
Classification
System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement
Approval for modifications to the software to 1) add the cruise control option to the Targis(TM) System treatment and 2) make minor changes to the operation ofd the coolant system.

Current openFDA PMA Record#

Device
UROLOGIX TARGIS SYSTEM
Applicant
Urologix, LLC
PMA number
P970008
Supplement
S011
Product code
MEQ
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date
1999-05-03
Decision code
APPR
Date received
1999-02-16
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for modifications to the software to 1) add the cruise control option to the Targis(TM) System treatment and 2) make minor changes to the operation ofd the coolant system.