Identity
- Trade Name
- EXABLATE 2000 SYSTEM FDA PMA
- Generic Name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided FDA PMA
Identifiers
- PMA Number
- P040003 FDA PMA
- FDA Product Code
- NRZ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Obstetrics/Gynecology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Exablate 2000 System is an MR-guided high intensity focused ultrasound (HIFU) ablation system. It is indicated for the ablation of uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine-sparing procedure.
Patients must have a uterine size of less than 24 weeks and have completed child bearing. The system received FDA PMA approval (P040003) and is classified as a Class III device under product code NRZ. It is manufactured by Insightec Ltd and supplied as a non-sterile, reusable system for use in clinical MRI environments.
Frequently asked questions
What is the Exablate 2000 System indicated for?
The Exablate 2000 System is indicated for the ablation of uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine-sparing procedure, as stated in the approval documentation.
What are the patient eligibility criteria for treatment with the Exablate 2000 System?
Patients must have a uterine size of less than 24 weeks and must have completed child bearing to be eligible for treatment with the Exablate 2000 System, according to the approval statement.
What regulatory authorization does the Exablate 2000 System have?
The Exablate 2000 System has FDA PMA approval, with application number P040003, and was approved on October 22, 2004, as indicated in 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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P040003 | Class III | Active |
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Manufacturer
- Manufacturer
- Insightec Ltd
- FDA Applicant
- Insightec, Ltd.
Sources (1)
- FDA PMA P040003 24 fields · synced Sep 18, 2026