PMA P150038S011

Device: Exablate 4000 System
Applicant: Insightec
PMA number: P150038
Supplement: S011
Product code: POH
Decision date: 2019-04-25
Classification: Mr-guided Focused Ultrasound System
Generic name: MR-guided focused ultrasound system
Approval order statement: Introduction of a US based warehouse and distribution facility for the purpose of receipt, handling, storage, shipping, and distributing of ExablateTreatment Kits and for storing replacement parts.

Current openFDA PMA Record#

Device: Exablate 4000 System
Applicant: Insightec
PMA number: P150038
Supplement: S011
Product code: POH
Generic name: MR-guided focused ultrasound system
Decision date: 2019-04-25
Decision code: OK30
Date received: 2019-03-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Introduction of a US based warehouse and distribution facility for the purpose of receipt, handling, storage, shipping, and distributing of ExablateTreatment Kits and for storing replacement parts.