PMA P150038S021
- Device
- Exablate 4000 (Exablate Neuro)
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S021
- Product code
- POH
- Decision date
- 2022-06-07
- Generic name
- MR-guided focused ultrasound system
- Approval order statement
- Approval for the replacement of the Control Personal Computer (PC) and Workstation PC to address end-of-life and software-related defects.
Current openFDA PMA Record#
- Device
- Exablate 4000 (Exablate Neuro)
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S021
- Product code
- POH
- Generic name
- MR-guided focused ultrasound system
- Decision date
- 2022-06-07
- Decision code
- APPR
- Date received
- 2022-03-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the replacement of the Control Personal Computer (PC) and Workstation PC to address end-of-life and software-related defects.