PMA P150038S020
- Device
- Exablate Model 4000 System
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S020
- Product code
- POH
- Decision date
- 2022-03-31
- Generic name
- MR-guided focused ultrasound system
- Approval order statement
- approval of a sandblasting machine and a dicing machine added to the production line at the Tirat Carmel, Israel facility
Current openFDA PMA Record#
- Device
- Exablate Model 4000 System
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S020
- Product code
- POH
- Generic name
- MR-guided focused ultrasound system
- Decision date
- 2022-03-31
- Decision code
- OK30
- Date received
- 2022-03-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of a sandblasting machine and a dicing machine added to the production line at the Tirat Carmel, Israel facility