PMA P030006S026

Device: PROLIEVE THERMODILATATION SYSTEM
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S026
Product code: MEQ
Decision date: 2014-10-24
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement: APPROVAL FOR REPLACING THE CURRENT SUPPLIER FOR MANIFOLD TUBING, AND TO REPLACE MEDICAL DEVICE ADHESIVE CURRENTLY USED IN MANUFACTURING.

Current openFDA PMA Record#

Device: PROLIEVE THERMODILATATION SYSTEM
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S026
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 2014-10-24
Decision code: APPR
Date received: 2014-05-21
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR REPLACING THE CURRENT SUPPLIER FOR MANIFOLD TUBING, AND TO REPLACE MEDICAL DEVICE ADHESIVE CURRENTLY USED IN MANUFACTURING.