PMA P040003S010
- Device
- EXABLATE
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S010
- Product code
- NRZ
- Decision date
- 2011-12-08
- 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 MODIFICATION OF THE EXABLATE PLATFORM 1) SO THAT THE SAME PLATFORM CAN BE USED WITH MULTIPLE CRADLES; AND 2) TO ENABLE THE CRADLE THAT HAS THE CAPABILITY TO MOVE THE TRANSDUCER IN THE ANTERIOR AND POSTERIOR DIRECTIONS BE USED IN THE LOCKED POSITION FORCOMMERCIAL UTERINE FIBROID TREATMENT.
Current openFDA PMA Record#
- Device
- EXABLATE
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S010
- Product code
- NRZ
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Decision date
- 2011-12-08
- Decision code
- APPR
- Date received
- 2011-09-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATION OF THE EXABLATE PLATFORM 1) SO THAT THE SAME PLATFORM CAN BE USED WITH MULTIPLE CRADLES; AND 2) TO ENABLE THE CRADLE THAT HAS THE CAPABILITY TO MOVE THE TRANSDUCER IN THE ANTERIOR AND POSTERIOR DIRECTIONS BE USED IN THE LOCKED POSITION FORCOMMERCIAL UTERINE FIBROID TREATMENT.