PMA P030006S018

Device: PROLIEVE THERMODILITATION SYSTEM
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S018
Product code: MEQ
Decision date: 2008-10-16
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement: APPROVAL FOR THE MODIFICATIONS TO THE PORLIEVE¿ HEAT EXCHANGER CARTRIDGE ASSEMBLY METHOD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROLIEVE¿ THERMODILITATION SYSTEM AND IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN.

Current openFDA PMA Record#

Device: PROLIEVE THERMODILITATION SYSTEM
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S018
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 2008-10-16
Decision code: APPR
Date received: 2008-06-05
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE MODIFICATIONS TO THE PORLIEVE¿ HEAT EXCHANGER CARTRIDGE ASSEMBLY METHOD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROLIEVE¿ THERMODILITATION SYSTEM AND IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN.