PROLIEVE THERMODILATATION SYSTEM
FDA premarket approval P030006 · decided 2004-02-19
Approval details
- PMA number
- P030006
- Trade name
- PROLIEVE THERMODILATATION SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Medifocus, Inc.
- Date received
- 2003-03-24
- Decision date
- 2004-02-19
- Days to decision
- 332 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Columbia, MD
- Statement
- APPROVAL THE PROLIEVE THERMODILATATION SYSTEM, WHICH IS A TRANSURETHRAL MICROWAVE THERAPY DEVICE THAT PROVIDES A NON-SURGICAL, MINIMALLY INVASIVE PROCEDURE FOR THE TREATMENT OF SYMPTOMATIC BHP 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) IN TYPICALLY INDICATED.
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