Exablate Model 4000 Type 1.0 and 1.1 System (Exablate Neuro)
FDA premarket approval P150038/S023 · decided 2022-11-02
Approval details
- PMA number
- P150038
- Supplement
- S023
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Exablate Model 4000 Type 1.0 and 1.1 System (Exablate Neuro)
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2022-08-05
- Decision date
- 2022-11-02
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Approval for the addition of another sterile disposable head ring screws (DHRS) option, manufactured by INSIGHTEC and marketed under a name PFK (Patient Fixation Kit), as an accessory to Exablate Neuro system.
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