PMA P150038S014

Device: Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)
Applicant: Insightec
PMA number: P150038
Supplement: S014
Product code: POH
Decision date: 2021-10-29
Generic name: MR-guided focused ultrasound system
Approval order statement: Approval for the Exablate Neuro. The device is indicated for use in the unilateral pallidotomy of patients with advanced, idiopathic Parkinsons disease with medication-refractory moderate to severe motor complications as an adjunct to Parkinsons disease medication treatment. Patients must be at least age 30. The designated area in the brain responsible for the movement disorder symptoms [globus pallidus (GPi)] must be identified and accessible for targeted thermal ablation by the Exablate device.

Current openFDA PMA Record#

Device: Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)
Applicant: Insightec
PMA number: P150038
Supplement: S014
Product code: POH
Generic name: MR-guided focused ultrasound system
Decision date: 2021-10-29
Decision code: APPR
Date received: 2021-03-31
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the Exablate Neuro. The device is indicated for use in the unilateral pallidotomy of patients with advanced, idiopathic Parkinsons disease with medication-refractory moderate to severe motor complications as an adjunct to Parkinsons disease medication treatment. Patients must be at least age 30. The designated area in the brain responsible for the movement disorder symptoms [globus pallidus (GPi)] must be identified and accessible for targeted thermal ablation by the Exablate device.