PMA P150031S073

Device: Vercise Genus Deep Brain Stimulation (DBS) System
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S073
Product code: NHL
Decision date: 2024-08-06
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: minor labeling updates associated with MR Conditionality for BSN DBS S8 and M8 Adapters with the Vercise Genus DBS System

Current openFDA PMA Record#

Device: Vercise Genus Deep Brain Stimulation (DBS) System
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S073
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2024-08-06
Decision code: APPR
Date received: 2024-05-08
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: minor labeling updates associated with MR Conditionality for BSN DBS S8 and M8 Adapters with the Vercise Genus DBS System