PMA P030006S005

Device: PROLIEVE THERMODILATATION SYSTEM CATHETER AND HEAT EXCHANGER
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S005
Product code: MEQ
Decision date: 2005-06-30
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement: APPROVAL FOR ACCELLENT JUAREZ (MANUFACTURING SITE) LOCATED IN, CHIHUAHUA, MEXICO; ACCELLENT EL PASO (WAREHOUSE) LOCATED IN EL PASO, TEXAS; AND STERIGENICS INTERNATIONAL, INC. (STERILIZER) LOCATED IN SANTA TERESA, NEW MEXICO.

Current openFDA PMA Record#

Device: PROLIEVE THERMODILATATION SYSTEM CATHETER AND HEAT EXCHANGER
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S005
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 2005-06-30
Decision code: APPR
Date received: 2005-03-23
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Express GMP Supplement
Approval order statement: APPROVAL FOR ACCELLENT JUAREZ (MANUFACTURING SITE) LOCATED IN, CHIHUAHUA, MEXICO; ACCELLENT EL PASO (WAREHOUSE) LOCATED IN EL PASO, TEXAS; AND STERIGENICS INTERNATIONAL, INC. (STERILIZER) LOCATED IN SANTA TERESA, NEW MEXICO.