EXABLATE 2000 SYSTEM
FDA premarket approval P040003 · decided 2004-10-22
Approval details
- PMA number
- P040003
- Trade name
- EXABLATE 2000 SYSTEM
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Applicant
- Insightec, Ltd.
- Date received
- 2004-01-27
- Decision date
- 2004-10-22
- Days to decision
- 269 days
- Decision code
- APPR
- Product code
- NRZ
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- Yes
- Location
- Dallas, TX
- Statement
- APPROVAL FOR THE EXABLATE 2000 SYSTEM. THE DEVICE IS INDICATED FOR ABLATION OF UTERINE FIBROID TISSUE IN PRE-OR PERI-MENOPAUSAL WOMEN WITH SYMPTOMATIC UTERINE FIBROIDS WHO DESIRE A UTERINE SPARING PROCEDURE. PATIENTS MUST HAVE A UTERINE SIZE OF LESS THAN 24 WEEKS AND HAVE COMPLETED CHILD BEARING.
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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 |