PMA P040003S006
- Device
- EXABLATE 2100 SYSTEM
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S006
- Product code
- NRZ
- Decision date
- 2009-12-22
- 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 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.
Current openFDA PMA Record#
- Device
- EXABLATE 2100 SYSTEM
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S006
- Product code
- NRZ
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Decision date
- 2009-12-22
- Decision code
- APPR
- Date received
- 2009-06-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.