PMA P150038S041
- Device
- EXABLATE
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S041
- Product code
- POH
- Decision date
- 2026-03-23
- Classification
- Neurology
- Generic name
- MR-guided focused ultrasound system
- Approval order statement
- Approval of the post-approval study (PAS) to comply with the conditions of approval outlined in our approval order for P150038/S037.
Current openFDA PMA Record#
- Device
- EXABLATE
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S041
- Product code
- POH
- Generic name
- MR-guided focused ultrasound system
- Decision date
- 2026-03-23
- Decision code
- APPR
- Date received
- 2025-11-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the post-approval study (PAS) to comply with the conditions of approval outlined in our approval order for P150038/S037.