Exablate 4000 (Exablate Neuro)
FDA premarket approval P150038/S029 · decided 2023-07-21
Approval details
- PMA number
- P150038
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Exablate 4000 (Exablate Neuro)
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2023-06-27
- Decision date
- 2023-07-21
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Change to the Exablate Neuro manufacturing process which involves the addition of a water recycling system for dicing machines.
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