PMA P150038S024
- Device
- Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S024
- Product code
- POH
- Decision date
- 2022-11-11
- Generic name
- MR-guided focused ultrasound system
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S024
- Product code
- POH
- Generic name
- MR-guided focused ultrasound system
- Decision date
- 2022-11-11
- Decision code
- APPR
- Date received
- 2022-10-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.