Exablate Model 4000 Type 1.0 and 1.1 Systems (Exablate Neuro)
FDA premarket approval P150038/S015 · decided 2023-07-18
Approval details
- PMA number
- P150038
- Supplement
- S015
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Exablate Model 4000 Type 1.0 and 1.1 Systems (Exablate Neuro)
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2021-06-11
- Decision date
- 2023-07-18
- Days to decision
- 767 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Approval for a change to the prescribers labeling to include the post-approval study (PAS) results from the 5-year follow-up.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.