PMA P970008S061

Device
UROLOGIX TARGIS SYSTEM
Applicant
Urologix, LLC
PMA number
P970008
Supplement
S061
Product code
MEQ
Decision date
2012-03-13
Classification
System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement
REPLACEMENT OF AN OBSOLETE PATIENT CABLE FIBER ST CONNECTOR USED IN THE MANUFACTURE OF THE TARGIS SYSTEM COOLWAVE CONTROL UNITS.

Current openFDA PMA Record#

Device
UROLOGIX TARGIS SYSTEM
Applicant
Urologix, LLC
PMA number
P970008
Supplement
S061
Product code
MEQ
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date
2012-03-13
Decision code
OK30
Date received
2012-02-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
REPLACEMENT OF AN OBSOLETE PATIENT CABLE FIBER ST CONNECTOR USED IN THE MANUFACTURE OF THE TARGIS SYSTEM COOLWAVE CONTROL UNITS.