PMA P040003S016
- Device
- EXABLATE
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S016
- Product code
- NRZ
- Decision date
- 2015-10-05
- 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 SOFTWARE OF THE EXABLATE SYSTEM INCLUDING ENABLING MOVEMENT OF THE TRANSDUCER IN THE ANTERIOR AND POSTERIOR DIRECTION. THE MODIFIED DEVICE IS REFERRED TO AS THE EXABLATE 2100 V1.1 WITH SOFTWARE VERSION 6.5.
Current openFDA PMA Record#
- Device
- EXABLATE
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S016
- Product code
- NRZ
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Decision date
- 2015-10-05
- Decision code
- APPR
- Date received
- 2015-04-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES TO THE SOFTWARE OF THE EXABLATE SYSTEM INCLUDING ENABLING MOVEMENT OF THE TRANSDUCER IN THE ANTERIOR AND POSTERIOR DIRECTION. THE MODIFIED DEVICE IS REFERRED TO AS THE EXABLATE 2100 V1.1 WITH SOFTWARE VERSION 6.5.