PMA P040003S015
- Device
- EXABLATE
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S015
- Product code
- NRZ
- Decision date
- 2015-08-31
- 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 CHANGES TO THE INDICATIONS FOR USE STATEMENT, PHYSICIAN LABELING, AND PATIENT LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EXABLATE MAGNETIC RESONANCE GUIDED FOCUSED ULTRASOUND SYSTEM AND IS INDICATED TO ABLATE 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.
Current openFDA PMA Record#
- Device
- EXABLATE
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S015
- Product code
- NRZ
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Decision date
- 2015-08-31
- Decision code
- APPR
- Date received
- 2015-03-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE INDICATIONS FOR USE STATEMENT, PHYSICIAN LABELING, AND PATIENT LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EXABLATE MAGNETIC RESONANCE GUIDED FOCUSED ULTRASOUND SYSTEM AND IS INDICATED TO ABLATE 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.