Identity
- Trade Name
- PROSTATRON FDA PMA
- Generic Name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy FDA PMA
Identifiers
- PMA Number
- P950014 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 Prostron System is a System, Hyperthermia, RF/Microwave (Benign Prostatic Hyperplasia), Thermotherapy, designed to deliver localized hyperthermia treatment for benign prostatic hyperplasia (BPH). It employs radiofrequency or microwave energy to induce controlled heating of prostate tissue, aiming to alleviate obstructive symptoms associated with enlarged prostate tissue.
This device is intended for use in clinical settings under the supervision of trained medical professionals. Supplied as a reusable system, it requires proper calibration and maintenance to ensure therapeutic efficacy and patient safety. The Prostron System holds FDA_PMA authorization under PMA number P950014, with regulatory classification as a Class III medical device. Storage and operational protocols must adhere to manufacturer guidelines to preserve performance and sterility where applicable.
Frequently asked questions
What is the Prostron System used for in clinical practice?
The Prostron System is designed to deliver localized hyperthermia treatment for benign prostatic hyperplasia (BPH). It uses radiofrequency or microwave energy to heat prostate tissue, aiming to reduce obstructive symptoms caused by an enlarged prostate. This procedure is performed under medical supervision in clinical settings.
Is the Prostron System reusable or single-use, and what does that mean for maintenance?
The Prostron System is a reusable device, meaning it is intended for repeated use across multiple patients. Since it is reusable, proper calibration and maintenance are required to ensure consistent performance, safety, and therapeutic effectiveness. The manufacturer provides guidelines for storage and operational protocols to maintain its functionality.
How is the Prostron System regulated, and what does that imply for its use?
The Prostron System holds FDA_PMA authorization under PMA number **P950014**, classifying it as a **Class III** medical device. This means it undergoes rigorous review by the FDA to ensure safety and effectiveness before market authorization. Clinicians must follow manufacturer instructions and regulatory guidelines to ensure proper use and compliance.
What storage requirements should be followed for the Prostron System?
The Prostron System must be stored according to the manufacturer’s guidelines to preserve its performance and ensure safety. Since it is reusable, sterility is not a primary concern for storage, but proper maintenance and calibration protocols must be adhered to. The manufacturer’s instructions should be consulted for specific storage conditions.
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 | P950014 | Class III | Active |
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Manufacturer
- Manufacturer
- Urologix, Inc.
Sources (1)
- FDA PMA P950014 24 fields · synced Sep 18, 2026