PMA P150031S080

Device: Vercise Genus Deep Brain Stimulation System
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S080
Product code: NHL
Decision date: 2024-12-23
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: The supplement was submitted as a part of an advisory issued in August 2024. The labeling change is to add the following warning to the ''Implanting the IPG'' Section (Step 15) of the Surgical Implant Manual:''Submuscular implant in the pectoral region (i.e. subpectoral) may expose the Vercise Genus rechargeable IPG to frequent muscle tension forces which may cause component damage (feedthrough wire(s)) resulting in device malfunction that could lead to adverse events including explant of the IPG”

Current openFDA PMA Record#

Device: Vercise Genus Deep Brain Stimulation System
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S080
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2024-12-23
Decision code: APPR
Date received: 2024-12-05
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: The supplement was submitted as a part of an advisory issued in August 2024. The labeling change is to add the following warning to the ''Implanting the IPG'' Section (Step 15) of the Surgical Implant Manual:''Submuscular implant in the pectoral region (i.e. subpectoral) may expose the Vercise Genus rechargeable IPG to frequent muscle tension forces which may cause component damage (feedthrough wire(s)) resulting in device malfunction that could lead to adverse events including explant of the IPG”