PMA P040003S019
- Device
- InSightec ExAblate System
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S019
- Product code
- NRZ
- Decision date
- 2016-10-28
- 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 the addition of adenomyosis to the list of conditions for which the safety and effectiveness of ExAblate have not been evaluated.
Current openFDA PMA Record#
- Device
- InSightec ExAblate System
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S019
- Product code
- NRZ
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Decision date
- 2016-10-28
- Decision code
- APPR
- Date received
- 2016-09-28
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of adenomyosis to the list of conditions for which the safety and effectiveness of ExAblate have not been evaluated.