PMA P150038S025
- Device
- Exablate Model 400 Type 1.0 & Type 1.1 (Exablate Neuro)
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S025
- Product code
- POH
- Decision date
- 2023-10-12
- Classification
- Neurology
- Generic name
- MR-guided focused ultrasound system
- Approval order statement
- approval for a new software version 9.0 and hardware changes for the Exablate Model 4000 Type 1.1 System
Current openFDA PMA Record#
- Device
- Exablate Model 400 Type 1.0 & Type 1.1 (Exablate Neuro)
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S025
- Product code
- POH
- Generic name
- MR-guided focused ultrasound system
- Decision date
- 2023-10-12
- Decision code
- APPR
- Date received
- 2023-01-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for a new software version 9.0 and hardware changes for the Exablate Model 4000 Type 1.1 System