Exablate Model 4000 Type 1.0 and 1.1 Systems (Exablate Neuro)
FDA premarket approval P150038/S026 · decided 2025-03-25
Approval details
- PMA number
- P150038
- Supplement
- S026
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Exablate Model 4000 Type 1.0 and 1.1 Systems (Exablate Neuro)
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2023-04-11
- Decision date
- 2025-03-25
- Days to decision
- 714 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- approval for a change to the prescribers labeling to include the post-approval study (PAS) results from the 5-year follow-up of the continued access cohort (ET002-CA) evaluated under investigational device exemption (IDE) G120246/S007 to continue use of the Exablate Neuro while the original PMA P150038 application was being reviewed by the FDA
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