PMA P040003S004
- Device
- EXABLATE 2000, VERSION 4.22
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S004
- Product code
- NRZ
- Decision date
- 2007-08-02
- 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 SEVERAL HARDWARE ENHANCEMENTS AND SOFTWARE ERROR CORRECTIONS.
Current openFDA PMA Record#
- Device
- EXABLATE 2000, VERSION 4.22
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S004
- Product code
- NRZ
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Decision date
- 2007-08-02
- Decision code
- APPR
- Date received
- 2007-04-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SEVERAL HARDWARE ENHANCEMENTS AND SOFTWARE ERROR CORRECTIONS.