PMA P040003S012
- Device
- EXABLATE SYSTEM
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S012
- Product code
- NRZ
- Decision date
- 2012-09-07
- Classification
- Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Approval order statement
- CHANGE IN THE MANUFACTURING OF THE TRANSDUCER FOR THE EXABLATE SYSTEM FROM A CONTRACT MANUFACTURER TO THE IN-HOUSE FACILITY.
Current openFDA PMA Record#
- Device
- EXABLATE SYSTEM
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S012
- Product code
- NRZ
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Decision date
- 2012-09-07
- Decision code
- OK30
- Date received
- 2012-08-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE MANUFACTURING OF THE TRANSDUCER FOR THE EXABLATE SYSTEM FROM A CONTRACT MANUFACTURER TO THE IN-HOUSE FACILITY.