Exablate Model 4000 Type 1.0 & Type 1.1 System (Exablate Neuro)
FDA premarket approval P150038/S033 · decided 2024-01-21
Approval details
- PMA number
- P150038
- Supplement
- S033
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- 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
- Date received
- 2023-11-22
- Decision date
- 2024-01-21
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- approval for a manufacturing site located at R.H. Electronics Ltd., 5 Hatzoref St. Har-Yona Industrial Area, Nof Hagalil, Nazereth Illit, 17000, Israel, for assembly activities of the Exablate Neuro treatment kits
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