PMA supplement
P040003 S022: Exablate 2000 System Magnetic Resonance Guided Focused Ultrasound Ablation of Uterine Fibroids
FDA PMA supplement · Normal 180 Day Track No User Fee · Insightec, Ltd.
Key facts
| Original PMA | P040003 |
|---|---|
| Supplement number | S022 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | Exablate 2000 System Magnetic Resonance Guided Focused Ultrasound Ablation of Uterine Fibroids |
| Generic name | Ablation system, high intensity focused ultrasound (HIFU), MR-guided |
| Applicant | Insightec, Ltd. |
| Product code | NRZ |
| Received date | Jun 25, 2025 |
| Decision date | Jul 23, 2025 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: