PMA P150038S034

Device: Exablate
Applicant: Insightec
PMA number: P150038
Supplement: S034
Product code: POH
Decision date: 2024-02-27
Classification: Neurology
Generic name: MR-guided focused ultrasound system
Approval order statement: a change of the manufacturing method for the head membrane rings from computer numerical control (CNC) machining to molding, and the manufacturing method of attaching the rings to head membrane was changed from screws to over-molding

Current openFDA PMA Record#

Device: Exablate
Applicant: Insightec
PMA number: P150038
Supplement: S034
Product code: POH
Generic name: MR-guided focused ultrasound system
Decision date: 2024-02-27
Decision code: OK30
Date received: 2024-01-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change of the manufacturing method for the head membrane rings from computer numerical control (CNC) machining to molding, and the manufacturing method of attaching the rings to head membrane was changed from screws to over-molding