PMA P150038S022

Device: Exablate 4000 System Type-1 (i.e. Type 1.0/1.1)
Applicant: Insightec
Product code: POH
Decision date: 2022-12-08
Generic name: MR-guided focused ultrasound system
Approval order statement: Approval for labeling changes to the indications for use of the device in idiopathic Essential tremor patients with medication-refractory tremor.

Current openFDA PMA Record#

Device: Exablate 4000 System Type-1 (i.e. Type 1.0/1.1)
Applicant: Insightec
PMA number: P150038
Supplement: S022
Product code: POH
Generic name: MR-guided focused ultrasound system
Decision date: 2022-12-08
Decision code: APPR
Date received: 2022-06-14
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for labeling changes to the indications for use of the device in idiopathic Essential tremor patients with medication-refractory tremor.