Exablate Model 4000 System Type 1.0 and 1.1 System (Exablate Neuro; Exablate Prime)
FDA premarket approval P150038/S039 · decided 2025-06-03
Approval details
- PMA number
- P150038
- Supplement
- S039
- Supplement type
- Real-Time Process
- Supplement reason
- 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
- Date received
- 2025-03-06
- Decision date
- 2025-06-03
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Approval for changes in the design of the Exablate Head Frame to include the option of anterior posts as a connection configuration and increase in inner diameter of the Patient Fixation Kit (PFK) Short Jacket adapter.
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