PMA P150038S026

Device: Exablate Model 4000 Type 1.0 and 1.1 Systems (“Exablate Neuro”)
Applicant: Insightec
PMA number: P150038
Supplement: S026
Product code: POH
Decision date: 2025-03-25
Classification: Neurology
Generic name: MR-guided focused ultrasound system
Approval order statement: approval for a change to the prescriber’s labeling to include the post-approval study (PAS) results from the 5-year follow-up of the continued access cohort (ET002-CA) evaluated under investigational device exemption (IDE) G120246/S007 to continue use of the Exablate Neuro while the original PMA P150038 application was being reviewed by the FDA

Current openFDA PMA Record#

Device: Exablate Model 4000 Type 1.0 and 1.1 Systems (“Exablate Neuro”)
Applicant: Insightec
PMA number: P150038
Supplement: S026
Product code: POH
Generic name: MR-guided focused ultrasound system
Decision date: 2025-03-25
Decision code: APPR
Date received: 2023-04-11
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: approval for a change to the prescriber’s labeling to include the post-approval study (PAS) results from the 5-year follow-up of the continued access cohort (ET002-CA) evaluated under investigational device exemption (IDE) G120246/S007 to continue use of the Exablate Neuro while the original PMA P150038 application was being reviewed by the FDA