PMA P030006S021

Device: PROLIEVE THERMODILITATION SYSTEM
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S021
Product code: MEQ
Decision date: 2009-06-19
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement: APPROVAL FOR MODIFICATION TO THE WELDING PROCESS THAT IS USED TO BOND THE CATHETER TIP TO THE CATHETER EXTRUSION FOR THE PROLIEVE TREATMENT CATHETER.

Current openFDA PMA Record#

Device: PROLIEVE THERMODILITATION SYSTEM
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S021
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 2009-06-19
Decision code: APPR
Date received: 2009-01-16
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR MODIFICATION TO THE WELDING PROCESS THAT IS USED TO BOND THE CATHETER TIP TO THE CATHETER EXTRUSION FOR THE PROLIEVE TREATMENT CATHETER.