PMA
P040003: EXABLATE 2000 SYSTEM
FDA PMA · Ablation system, high intensity focused ultrasound (HIFU), MR-guided · Insightec, Ltd.
Key facts
| PMA number | P040003 |
|---|---|
| Trade name | EXABLATE 2000 SYSTEM |
| Generic name | Ablation system, high intensity focused ultrasound (HIFU), MR-guided |
| Applicant | Insightec, Ltd. |
| Owner/operator | INSIGHTEC |
| Product code | NRZ |
| Approval date | Oct 22, 2004 |
| Docket number | 05M-0473 |
| Notice date | Nov 28, 2005 |
| Establishment registration | 3007145736 |
| FEI number | 3003004504 |
At a glance
- 10–99 Supplements
- Jul 23, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: