PMA P030006S022

Device: PROLIEVE THERMODILITATION SYSTEM
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S022
Product code: MEQ
Decision date: 2009-11-23
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement: APPROVAL FOR SPECIFIC MODIFICATIONS TO THE TREATMENT CATHETER DESIGN, CATHETER MANUFACTURING PROCESSES, AND CATHETER SPECIFICATIONS.

Current openFDA PMA Record#

Device: PROLIEVE THERMODILITATION SYSTEM
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S022
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 2009-11-23
Decision code: APPR
Date received: 2009-04-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR SPECIFIC MODIFICATIONS TO THE TREATMENT CATHETER DESIGN, CATHETER MANUFACTURING PROCESSES, AND CATHETER SPECIFICATIONS.