PMA P150038S003

Device: ExAblate
Applicant: Insightec
PMA number: P150038
Supplement: S003
Product code: POH
Decision date: 2017-06-26
Classification: Mr-guided Focused Ultrasound System
Generic name: MR-guided focused ultrasound system
Approval order statement: Approval for a software maintenance upgrade from Software Version 6.6 to Version 7.0 for the unilateral Thalamotomy treatment of idiopathic Essential Tremor (ET) patients with medication –refractory tremor.

Current openFDA PMA Record#

Device: ExAblate
Applicant: Insightec
PMA number: P150038
Supplement: S003
Product code: POH
Generic name: MR-guided focused ultrasound system
Decision date: 2017-06-26
Decision code: APPR
Date received: 2017-03-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a software maintenance upgrade from Software Version 6.6 to Version 7.0 for the unilateral Thalamotomy treatment of idiopathic Essential Tremor (ET) patients with medication –refractory tremor.