PMA P150031S075

Device: Vercise Genus Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S075
Product code: NHL
Decision date: 2024-07-26
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: to add an alternate Sterile Pack Automation System for the WaveWriter Alpha and Vercise Genus Implantable Pulse Generator (IPG) devices at Boston Scientific Corporation (BSC) Clonmel.

Current openFDA PMA Record#

Device: Vercise Genus Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S075
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2024-07-26
Decision code: OK30
Date received: 2024-06-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to add an alternate Sterile Pack Automation System for the WaveWriter Alpha and Vercise Genus Implantable Pulse Generator (IPG) devices at Boston Scientific Corporation (BSC) Clonmel.