PMA P970008S029

Device: UROLOGIX TARGIS SYSTEM
Applicant: Urologix, LLC
PMA number: P970008
Supplement: S029
Product code: MEQ
Decision date: 2006-03-23
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement: APPROVAL FOR THE ADDITION OF A RADIO FREQUENCY IDENTIFICATION (RFID) SYSTEM TO PREVENT REUSE OF THE DISPOSABLE DEVICE COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLOGIX TARGIS SYSTEM AND IS INDICATED FOR THE DELIVERY OF MICROWAVE ENERGY TO THE PROSTATE FOR THE TREATMENT OF BPH IN A SINGLE SESSION. IT IS INDICATED FOR PATIENTS WITH PROSTATIC LENGTHS OF 30 TO 50 MM.

Current openFDA PMA Record#

Device: UROLOGIX TARGIS SYSTEM
Applicant: Urologix, LLC
PMA number: P970008
Supplement: S029
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 2006-03-23
Decision code: APPR
Date received: 2005-05-10
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF A RADIO FREQUENCY IDENTIFICATION (RFID) SYSTEM TO PREVENT REUSE OF THE DISPOSABLE DEVICE COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLOGIX TARGIS SYSTEM AND IS INDICATED FOR THE DELIVERY OF MICROWAVE ENERGY TO THE PROSTATE FOR THE TREATMENT OF BPH IN A SINGLE SESSION. IT IS INDICATED FOR PATIENTS WITH PROSTATIC LENGTHS OF 30 TO 50 MM.