Exablate 2000 System Magnetic Resonance Guided Focused Ultrasound Ablation of Uterine Fibroids
FDA premarket approval P040003/S022 · decided 2025-07-23
Approval details
- PMA number
- P040003
- Supplement
- S022
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Exablate 2000 System Magnetic Resonance Guided Focused Ultrasound Ablation of Uterine Fibroids
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Applicant
- Insightec, Ltd.
- Date received
- 2025-06-25
- Decision date
- 2025-07-23
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NRZ
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Dallas, TX
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 (K231378) | Insightec, Ltd. | 2023-10-30 |