PMA P030006S002

Device: CELSION PROLIEVE THERMODILATATION SYSTEM
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S002
Product code: MEQ
Decision date: 2004-09-17
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement: APPROVAL FOR SOFTWARE MODIFICATIONS INCLUDING ADJUSTMENT OF TOLERANCE LIMITS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROLIEVE THERMODILATION SYSTEM (PROLIEVE). PROLIEVE IS A TRANSURETHRAL MICROWAVE THERAPY DEVICE THAT PROVIDES A NON-SURGICAL, MINIMALLY INVASIVE PROCEDURE FOR THE TREATMENT OF SYMPTOMATIC BPH IN MEN WITH A PROSTATE SIZE OF 20 TO 80 GRAMS, A PROSTATIC URETHRA LENGTH OF 1.2 TO 5.5 CM AND IN WHOM DRUG THERAPY (E.G., PROSCAR) IS TYPICALLY INDICATED.

Current openFDA PMA Record#

Device: CELSION PROLIEVE THERMODILATATION SYSTEM
Applicant: Medifocus, Inc.
PMA number: P030006
Supplement: S002
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 2004-09-17
Decision code: APPR
Date received: 2004-08-18
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR SOFTWARE MODIFICATIONS INCLUDING ADJUSTMENT OF TOLERANCE LIMITS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROLIEVE THERMODILATION SYSTEM (PROLIEVE). PROLIEVE IS A TRANSURETHRAL MICROWAVE THERAPY DEVICE THAT PROVIDES A NON-SURGICAL, MINIMALLY INVASIVE PROCEDURE FOR THE TREATMENT OF SYMPTOMATIC BPH IN MEN WITH A PROSTATE SIZE OF 20 TO 80 GRAMS, A PROSTATIC URETHRA LENGTH OF 1.2 TO 5.5 CM AND IN WHOM DRUG THERAPY (E.G., PROSCAR) IS TYPICALLY INDICATED.