PMA
P150038: EXABLATE
FDA PMA · MR-guided focused ultrasound system · Insightec
Key facts
| PMA number | P150038 |
|---|---|
| Trade name | EXABLATE |
| Generic name | MR-guided focused ultrasound system |
| Applicant | Insightec |
| Owner/operator | INSIGHTEC |
| Product code | POH |
| Approval date | Jul 11, 2016 |
| Docket number | 16M-2183 |
| Notice date | Jul 25, 2016 |
| Establishment registration | 9615058 |
| FEI number | 3003105983 |
At a glance
- 10–99 Supplements
- Sep 16, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: