PMA P150038S008
- Device
- ExAblate (Model 4000) System
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S008
- Product code
- POH
- Decision date
- 2018-10-24
- Classification
- Mr-guided Focused Ultrasound System
- Generic name
- MR-guided focused ultrasound system
- Approval order statement
- Approval to include the 2-year and 3-year post-market study outcomes in the device labeling.
Current openFDA PMA Record#
- Device
- ExAblate (Model 4000) System
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S008
- Product code
- POH
- Generic name
- MR-guided focused ultrasound system
- Decision date
- 2018-10-24
- Decision code
- APPR
- Date received
- 2018-07-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to include the 2-year and 3-year post-market study outcomes in the device labeling.