Exablate 4000 (Exablate Neuro)
FDA premarket approval P150038/S021 · decided 2022-06-07
Approval details
- PMA number
- P150038
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Exablate 4000 (Exablate Neuro)
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2022-03-10
- Decision date
- 2022-06-07
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Approval for the replacement of the Control Personal Computer (PC) and Workstation PC to address end-of-life and software-related defects.
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