TARGIS Targeted Transurethral Thermoablation System (TARGIS System): New Pouch Sealer
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- TARGIS (T3) SYSTEM FDA PMA
- Generic Name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy FDA PMA
Identifiers
- PMA Number
- P970008 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 TARGIS Targeted Transurethral Thermoablation System (TARGIS System) is a hyperthermia system using RF/microwave energy for thermotherapy in the treatment of benign prostatic hyperplasia (BPH). It is indicated to relieve symptoms associated with BPH in men with prostatic lengths between 30 and 50 millimeters.
This system is supplied as a reusable device and includes a new pouch sealer component. It received FDA PMA approval (P970008) on August 22, 1997, and is manufactured by Urologix, LLC in Plymouth, Minnesota. The device is intended for use in clinical settings under professional supervision.
Frequently asked questions
What is the TARGIS System indicated to treat?
The TARGIS System is indicated to relieve symptoms associated with benign prostatic hyperplasia (BPH) in men with prostatic lengths of 30 to 50 millimeters, as stated in the approval documentation for Model 4000.
Is the TARGIS System a single-use or reusable device?
The TARGIS System is a reusable device, as indicated by its classification and the inclusion of components like the new pouch sealer, which is part of a system designed for multiple uses under proper reprocessing.
What regulatory authorization does the TARGIS System have?
The TARGIS System has FDA Premarket Approval (PMA) under number P970008, which was granted on August 22, 1997, for the Model 4000 version of the device.
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 | P970008 | Class III | Active |
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Manufacturer
- Manufacturer
- Urologix, LLC
Sources (1)
- FDA PMA P970008 24 fields · synced Sep 18, 2026