PMA P030006S010

Device: PROLIEVE THERMODILATATION SYSTEM
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S010
Product code: MEQ
Decision date: 2006-01-20
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement: APPROVAL FOR A NEW SANMINA-SCI CORPORATION MANUFACTURING SITE LOCATED IN HUNTSVILLE, ALABAMA TO MANUFACTURE THE PROLIEVE THERMODILATATION SYSTEM CONSOLE AND RECTAL TEMPERATURE MONITOR.

Current openFDA PMA Record#

Device: PROLIEVE THERMODILATATION SYSTEM
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S010
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 2006-01-20
Decision code: APPR
Date received: 2005-12-01
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A NEW SANMINA-SCI CORPORATION MANUFACTURING SITE LOCATED IN HUNTSVILLE, ALABAMA TO MANUFACTURE THE PROLIEVE THERMODILATATION SYSTEM CONSOLE AND RECTAL TEMPERATURE MONITOR.