PMA P970008S018

Device: UROLOGIX TARGIS SYSTEM
Applicant: Urologix, LLC
PMA number: P970008
Supplement: S018
Product code: MEQ
Decision date: 2002-09-04
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement: APPROVAL FOR A CHANGE FROM THE STANDARD ANTENNA (2.8 CM IN LENGTH) TO A SHORTENED VERSION (2.0 CM IN LENGTH). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLOGIX TARGIS SYSTEM, AND IS INTENDED TO RELIEVE SYMPTOMS AND OBSTRUCTION ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASMIA (BPH), AND IS INDICATED FOR MEN WITH PROSTATIC URETHRA LENGTHS OF 2.5 TO 3.5 CM.

Current openFDA PMA Record#

Device: UROLOGIX TARGIS SYSTEM
Applicant: Urologix, LLC
PMA number: P970008
Supplement: S018
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 2002-09-04
Decision code: APPR
Date received: 2001-12-03
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE FROM THE STANDARD ANTENNA (2.8 CM IN LENGTH) TO A SHORTENED VERSION (2.0 CM IN LENGTH). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLOGIX TARGIS SYSTEM, AND IS INTENDED TO RELIEVE SYMPTOMS AND OBSTRUCTION ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASMIA (BPH), AND IS INDICATED FOR MEN WITH PROSTATIC URETHRA LENGTHS OF 2.5 TO 3.5 CM.