PMA P040003S009
- Device
- EXABLATE 2000/2100 1.5 AND 3T
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S009
- Product code
- NRZ
- Decision date
- 2011-08-09
- 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 UPDATED LABELING INCLUDING LONG-TERM DATA FROM THE POST-APPROVAL STUDY.
Current openFDA PMA Record#
- Device
- EXABLATE 2000/2100 1.5 AND 3T
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S009
- Product code
- NRZ
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Decision date
- 2011-08-09
- Decision code
- APPR
- Date received
- 2010-07-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR UPDATED LABELING INCLUDING LONG-TERM DATA FROM THE POST-APPROVAL STUDY.