PMA P040003S005
- Device
- EXABLATE 2000 SYSTEM
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S005
- Product code
- NRZ
- Decision date
- 2009-03-04
- 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 LABELING AND TREATMENT PROTOCOL CHANGES. THE DEVICE, AS MODIFIED, WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAME EXABLATE 2000 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. LIMITED INFORMATION IS AVAILABLE REGARDING THE SAFETY AND EFFECTIVENESS OF THE EXABLATE AS A TREATMENT FOR WOMEN WHO DESIRE PREGNANCY. PATIENTS SHOULD HAVE COMPLETED CHILD BEARING.
Current openFDA PMA Record#
- Device
- EXABLATE 2000 SYSTEM
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S005
- Product code
- NRZ
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Decision date
- 2009-03-04
- Decision code
- APPR
- Date received
- 2008-09-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING AND TREATMENT PROTOCOL CHANGES. THE DEVICE, AS MODIFIED, WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAME EXABLATE 2000 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. LIMITED INFORMATION IS AVAILABLE REGARDING THE SAFETY AND EFFECTIVENESS OF THE EXABLATE AS A TREATMENT FOR WOMEN WHO DESIRE PREGNANCY. PATIENTS SHOULD HAVE COMPLETED CHILD BEARING.