PMA supplement
P150038 S039: Exablate Model 4000 System Type 1.0 and 1.1 System (“Exablate Neuro”; “Exablate Prime”)
FDA PMA supplement · Real-Time Process · Insightec
Key facts
| Original PMA | P150038 |
|---|---|
| Supplement number | S039 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Exablate Model 4000 System Type 1.0 and 1.1 System (“Exablate Neuro”; “Exablate Prime”) |
| Generic name | MR-guided focused ultrasound system |
| Applicant | Insightec |
| Product code | POH |
| Received date | Mar 6, 2025 |
| Decision date | Jun 3, 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: