PMA P040003S017
- Device
- EXABLATE 2000 SYSTEM
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S017
- Product code
- NRZ
- Decision date
- 2016-06-27
- Classification
- Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Approval order statement
- Approval for updates to the software to change the operating system and fix minor software defects.
Current openFDA PMA Record#
- Device
- EXABLATE 2000 SYSTEM
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S017
- Product code
- NRZ
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Decision date
- 2016-06-27
- Decision code
- APPR
- Date received
- 2016-04-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updates to the software to change the operating system and fix minor software defects.