PMA P150038

Device: Exablate Model 4000 System
Applicant: Insightec
PMA number: P150038
Supplement: S024
Product code: POH
Decision date: 2026-09-16
Generic name: MR-guided focused ultrasound system
Approval order statement: approval for a manufacturing site located at Molded Rubber and Plastics Corporation, 13161 W. Glendale Avenue, Butler, WI 53007, USA. This new site will be an additional manufacturing site for the Exablate 4000 Treatment Kits.

Current openFDA PMA Record#

Device: Exablate Model 4000 System
Applicant: Insightec
PMA number: P150038
Supplement: S044
Product code: POH
Generic name: MR-guided focused ultrasound system
Decision date: 2026-09-16
Decision code: APPR
Date received: 2026-03-19
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a manufacturing site located at Molded Rubber and Plastics Corporation, 13161 W. Glendale Avenue, Butler, WI 53007, USA. This new site will be an additional manufacturing site for the Exablate 4000 Treatment Kits.