PMA P150038S035
- Device
- Exablate Model 4000 Type 1.0 & Type 1.1 System, Exablate Neuro
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S035
- Product code
- POH
- Decision date
- 2024-02-26
- Classification
- Neurology
- Generic name
- MR-guided focused ultrasound system
- Approval order statement
- a change to the in-process specification of the individual tile level impedance testing to accept a different range of impedances
Current openFDA PMA Record#
- Device
- Exablate Model 4000 Type 1.0 & Type 1.1 System, Exablate Neuro
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S035
- Product code
- POH
- Generic name
- MR-guided focused ultrasound system
- Decision date
- 2024-02-26
- Decision code
- OK30
- Date received
- 2024-01-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the in-process specification of the individual tile level impedance testing to accept a different range of impedances