PMA P150038S037

Device: Exablate Model 4000 Type-1 System
Applicant: Insightec
PMA number: P150038
Supplement: S037
Product code: POH
Decision date: 2025-07-03
Classification: Neurology
Generic name: MR-guided focused ultrasound system
Approval order statement: The Exablate Neuro is intended indicated for use in the unilateral pallidothalamic tractotomy of advanced idiopathic Parkinson’s Disease with medication-refractory moderate to severe motor complications as an adjunct to Parkinson’s disease medication treatment, and in the staged (by at least 6 months from the first pallidothalamic tractotomy), unilateral pallidothalamic tractotomy of idiopathic Parkinson’s Disease with medication-refractory motor complications of their contralateral side that was not previously treated in the first unilateral pallidothalamic tractotomy. Patients must be at least age 30. The designated area in the brain responsible for the motor complications symptoms (pallidothalamic tract) must be identified and accessible for targeted thermal ablation by the Exablate device.

Current openFDA PMA Record#

Device: Exablate Model 4000 Type-1 System
Applicant: Insightec
PMA number: P150038
Supplement: S037
Product code: POH
Generic name: MR-guided focused ultrasound system
Decision date: 2025-07-03
Decision code: APPR
Date received: 2024-07-16
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: The Exablate Neuro is intended indicated for use in the unilateral pallidothalamic tractotomy of advanced idiopathic Parkinson’s Disease with medication-refractory moderate to severe motor complications as an adjunct to Parkinson’s disease medication treatment, and in the staged (by at least 6 months from the first pallidothalamic tractotomy), unilateral pallidothalamic tractotomy of idiopathic Parkinson’s Disease with medication-refractory motor complications of their contralateral side that was not previously treated in the first unilateral pallidothalamic tractotomy. Patients must be at least age 30. The designated area in the brain responsible for the motor complications symptoms (pallidothalamic tract) must be identified and accessible for targeted thermal ablation by the Exablate device.