PMA P150038S030
- Device
- Exablate Model 4000 System
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S030
- Product code
- POH
- Decision date
- 2023-07-21
- Classification
- Neurology
- Generic name
- MR-guided focused ultrasound system
- Approval order statement
- Adding a contract manufacturer for the assembly of the head coils and membranes, and adding a label with serial number on the coils for warehouse goods tracking.
Current openFDA PMA Record#
- Device
- Exablate Model 4000 System
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S030
- Product code
- POH
- Generic name
- MR-guided focused ultrasound system
- Decision date
- 2023-07-21
- Decision code
- OK30
- Date received
- 2023-06-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding a contract manufacturer for the assembly of the head coils and membranes, and adding a label with serial number on the coils for warehouse goods tracking.