PMA P040003S011
- Device
- EXABLATE DEVICE
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S011
- Product code
- NRZ
- Decision date
- 2012-05-01
- 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 CHANGES INCLUDING: 1) DELETION OF THE COMMENT (OUTCOMES OF 10 PREGNANCIES ARE PENDING AS OF AUGUST 2008, AND OUTCOME OF ONE PREGNANCY IS UNKNOWN.) AND ADDITION OF DEEP VEIN THROMBOSIS UNDER THE SECTION ENTITLED OTHER ADVERSE EVENTS.
Current openFDA PMA Record#
- Device
- EXABLATE DEVICE
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S011
- Product code
- NRZ
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Decision date
- 2012-05-01
- Decision code
- APPR
- Date received
- 2012-04-09
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES INCLUDING: 1) DELETION OF THE COMMENT (OUTCOMES OF 10 PREGNANCIES ARE PENDING AS OF AUGUST 2008, AND OUTCOME OF ONE PREGNANCY IS UNKNOWN.) AND ADDITION OF DEEP VEIN THROMBOSIS UNDER THE SECTION ENTITLED OTHER ADVERSE EVENTS.