PMA supplement
P150038 S014: Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)
FDA PMA supplement · Panel Track · Insightec
Key facts
| Original PMA | P150038 |
|---|---|
| Supplement number | S014 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) |
| Generic name | MR-guided focused ultrasound system |
| Applicant | Insightec |
| Product code | POH |
| Received date | Mar 31, 2021 |
| Decision date | Oct 29, 2021 |
| Docket number | 21M-1182 |
| Notice date | Nov 3, 2021 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: