PMA P150038S002
- Device
- EXABLATE
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S002
- Product code
- POH
- Decision date
- 2017-04-17
- Classification
- Mr-guided Focused Ultrasound System
- Generic name
- MR-guided focused ultrasound system
- Approval order statement
- Approval for a new Magnetic Resonance (MR) Head Coil for compatibility and use with the 1.5 Tesla (T) MR scanner environment when used with the ExAblate Model 4000 Type 1.0 System.
Current openFDA PMA Record#
- Device
- EXABLATE
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S002
- Product code
- POH
- Generic name
- MR-guided focused ultrasound system
- Decision date
- 2017-04-17
- Decision code
- APPR
- Date received
- 2017-01-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new Magnetic Resonance (MR) Head Coil for compatibility and use with the 1.5 Tesla (T) MR scanner environment when used with the ExAblate Model 4000 Type 1.0 System.