PMA P110039S004
- Device
- EXABLATE 2000/2100
- Applicant
- Insightec
- PMA number
- P110039
- Supplement
- S004
- Product code
- NRZ
- Decision date
- 2013-12-17
- 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 A MINOR SOFTWARE CHANGE OF THE EXABLATE SYSTEM TO ADDRESS THE MICRO-SWITCH ERROR.
Current openFDA PMA Record#
- Device
- EXABLATE 2000/2100
- Applicant
- Insightec
- PMA number
- P110039
- Supplement
- S004
- Product code
- NRZ
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Decision date
- 2013-12-17
- Decision code
- APPR
- Date received
- 2013-09-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MINOR SOFTWARE CHANGE OF THE EXABLATE SYSTEM TO ADDRESS THE MICRO-SWITCH ERROR.