Identity
- Trade Name
- PROLIEVE THERMODILATATION SYSTEM FDA PMA
- Generic Name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy FDA PMA
Identifiers
- PMA Number
- P030006 FDA PMA
- FDA Product Code
- MEQ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The ProLieve Thermodilation System is a transurethral microwave therapy device that provides a non-surgical, minimally invasive procedure for the treatment of symptomatic benign prostatic hyperplasia (BPH). It is designed for use in men with a prostate size of 20 to 80 grams and a prostatic urethra length of 1.2 to 5.5 cm.
The system is supplied as a reusable device intended for use in clinical settings under medical supervision. It has received FDA PMA approval (P030006) and is indicated for patients in whom drug therapy (e.g., Proscar) is typically indicated.
Frequently asked questions
What is the ProLieve Thermodilation System used for?
The ProLieve Thermodilation System is used for the non-surgical, minimally invasive treatment of symptomatic benign prostatic hyperplasia (BPH) in men with a prostate size between 20 and 80 grams and a prostatic urethra length of 1.2 to 5.5 cm, particularly when drug therapy such as Proscar is typically indicated.
Who manufactures the ProLieve Thermodilation System?
The ProLieve Thermodilation System is manufactured by Medifocus, Inc., which is listed as the applicant and manufacturer in the FDA PMA submission (P030006) with headquarters in Columbia, MD.
Is the ProLieve Thermodilation System a surgical device?
No, the ProLieve Thermodilation System is not a surgical device; it is explicitly described as providing a non-surgical, minimally invasive procedure for treating BPH via transurethral microwave therapy.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P030006 | Class III | Active |
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Manufacturer
- Manufacturer
- Medifocus, Inc.
Sources (1)
- FDA PMA P030006 24 fields · synced Sep 18, 2026