PMA P040003S018
- Device
- EXABLATE 2000 SYSTEM
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S018
- Product code
- NRZ
- Decision date
- 2016-08-26
- 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 change to the ExAblate system to comply with the European directive 2002/95/EC and 2011/65/EU in relation to Restriction of Hazardous Substance (RoHS).
Current openFDA PMA Record#
- Device
- EXABLATE 2000 SYSTEM
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S018
- Product code
- NRZ
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Decision date
- 2016-08-26
- Decision code
- APPR
- Date received
- 2016-05-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for change to the ExAblate system to comply with the European directive 2002/95/EC and 2011/65/EU in relation to Restriction of Hazardous Substance (RoHS).