PMA P040003
- Device
- Exablate 2000 System Magnetic Resonance Guided Focused Ultrasound Ablation of Uterine Fibroids
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S021
- Product code
- NRZ
- Decision date
- 2025-07-23
- Classification
- Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Approval order statement
- You proposed to change the total number of enrolled subjects from 200 to 198. Based upon the information submitted, the PMA supplement is approved.
Current openFDA PMA Record#
- Device
- Exablate 2000 System Magnetic Resonance Guided Focused Ultrasound Ablation of Uterine Fibroids
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S022
- Product code
- NRZ
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Decision date
- 2025-07-23
- Decision code
- APPR
- Date received
- 2025-06-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- You proposed to change the total number of enrolled subjects from 200 to 198. Based upon the information submitted, the PMA supplement is approved.