EXABLATE 2100 SYSTEM
FDA premarket approval P040003/S006 · decided 2009-12-22
Approval details
- PMA number
- P040003
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXABLATE 2100 SYSTEM
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Applicant
- Insightec, Ltd.
- Date received
- 2009-06-05
- Decision date
- 2009-12-22
- Days to decision
- 200 days
- Decision code
- APPR
- Product code
- NRZ
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Dallas, TX
- Statement
- APPROVAL FOR ADDITION OF ENHANCED SONICATION, A DETACHABLE CRADLE, AND SEVERAL OTHER MODIFICATIONS TO THE EXABLATE 2000 SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EXABLATE 2100 AND IS INDICATED FOR ABLATION OF UTERINE FIBROID TISSUE IN PRE- OR PERI-MENOPAUSAL WOMEN WITH SYMPTOMATIC UTERINE FIBROIDS WHO DESIRE A UTERINE SPARING PROCEDURE AND WHOSE UTERINE SIZE IS LESS THAN 24 WEEKS. PATIENTS SHOULD 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 |