PMA P150038S015
- Device
- Exablate Model 4000 Type 1.0 and 1.1 Systems (“Exablate Neuro”)
- Applicant
- Insightec
- Product code
- POH
- Decision date
- 2023-07-18
- Generic name
- MR-guided focused ultrasound system
- Approval order statement
- Approval for a change to the prescribers labeling to include the post-approval study (PAS) results from the 5-year follow-up.
Current openFDA PMA Record#
- Device
- Exablate Model 4000 Type 1.0 and 1.1 Systems (“Exablate Neuro”)
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S015
- Product code
- POH
- Generic name
- MR-guided focused ultrasound system
- Decision date
- 2023-07-18
- Decision code
- APPR
- Date received
- 2021-06-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for a change to the prescribers labeling to include the post-approval study (PAS) results from the 5-year follow-up.