PMA P950014S022

Device: PROSTATRON PRAKTIS
Applicant: Urologix, Inc.
PMA number: P950014
Supplement: S022
Product code: MEQ
Decision date: 2004-06-10
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement: APPROVAL FOR DESIGN CHANGES TO INCLUDE CHANGING THE CONTACTS ON THE INTERNAL WIRING FROM TIN TO GOLD AND A MODIFICATION TO THE SOFTWARE TO INCLUDE AN ADDITIONAL ALARM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROSTATRON PRAKTIS AND IS INDICATED FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH).

Current openFDA PMA Record#

Device: PROSTATRON PRAKTIS
Applicant: Urologix, Inc.
PMA number: P950014
Supplement: S022
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 2004-06-10
Decision code: APPR
Date received: 2004-05-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR DESIGN CHANGES TO INCLUDE CHANGING THE CONTACTS ON THE INTERNAL WIRING FROM TIN TO GOLD AND A MODIFICATION TO THE SOFTWARE TO INCLUDE AN ADDITIONAL ALARM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROSTATRON PRAKTIS AND IS INDICATED FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH).