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Dornier Urowave Microwave Thermotherapy System

FDA PMA

Class III (US FDA PMA)

PMA P970044

by Dornier MedTech America, Inc.

Identity

Trade Name
DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM FDA PMA
Generic Name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy FDA PMA

Identifiers

PMA Number
P970044 FDA PMA
FDA Product Code
MEQ FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Gastroenterology, Urology FDA PMA
FDA Decision
APWD FDA PMA

The Dornier Urowave Microwave Thermotherapy System is indicated as a non-surgical treatment alternative to transurethral resection of the prostate (TURP) for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with prostatic lengths between 30 mm and 55 mm. It delivers microwave energy to prostatic tissue to achieve therapeutic hyperthermia.

The system is supplied as a reusable device for use in clinical settings under medical supervision. It has received FDA PMA authorization (P970044) and is classified as a Class III device under product code MEQ. No information regarding sterility, single-use status, MRI safety, sizes, or storage is provided in the source data.

Frequently asked questions

What is the Dornier Urowave Microwave Thermotherapy System used for?

The Dornier Urowave Microwave Thermotherapy System is indicated as a non-surgical treatment alternative to transurethral resection of the prostate (TURP) for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with prostatic lengths between 30 mm and 55 mm, based on the device's official indication statement.

Is the Dornier Urowave Microwave Thermotherapy System a surgically implanted device?

No, the Dornier Urowave Microwave Thermotherapy System is not a surgically implanted device. It is indicated as a non-surgical treatment alternative to TURP, meaning it treats BPH without requiring surgical resection of prostate tissue.

What regulatory authorization does the Dornier Urowave Microwave Thermotherapy System have?

The Dornier Urowave Microwave Thermotherapy System has received FDA Premarket Approval (PMA) under application number P970044, as stated in the AUTHORIZATIONS and pma_number fields of the device data.

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. Sources consulted: Dornier MedTech - A Leading Urological Medical Device Company

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Dornier MedTech America, Inc.

Sources (1)

  • FDA PMA P970044 24 fields · synced Oct 6, 2026