PMA P030006S011

Device: PROLIEVE THERMODILATATION SYSTEM
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S011
Product code: MEQ
Decision date: 2006-08-10
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement: APPROVAL FOR MANUFACTURING CHANGES TO CORRECT THE INNER MANIFOLD BOND OF THE CATHETER AND TO CONFIRM DIMENSIONS OF TUBING USED WITH THE HEAT EXCHANGER.

Current openFDA PMA Record#

Device: PROLIEVE THERMODILATATION SYSTEM
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S011
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 2006-08-10
Decision code: APPR
Date received: 2006-06-26
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MANUFACTURING CHANGES TO CORRECT THE INNER MANIFOLD BOND OF THE CATHETER AND TO CONFIRM DIMENSIONS OF TUBING USED WITH THE HEAT EXCHANGER.