PMA supplement
P150038 S033: Exablate Model 4000 Type 1.0 & Type 1.1 System (“Exablate Neuro”)
FDA PMA supplement · Normal 180 Day Track No User Fee · Insightec
Key facts
| Original PMA | P150038 |
|---|---|
| Supplement number | S033 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Exablate Model 4000 Type 1.0 & Type 1.1 System (“Exablate Neuro”) |
| Generic name | MR-guided focused ultrasound system |
| Applicant | Insightec |
| Product code | POH |
| Received date | Nov 22, 2023 |
| Decision date | Jan 21, 2024 |
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: