PMA P150031S076

Device: Vercise™ DBS Controller
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S076
Product code: NHL
Decision date: 2025-02-05
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: approval for the Vercise™ DBS Controller, a mobile application intended to function as an alternate to the current Vercise™ Remote Control (RC) 4 (approved in P150031/S034) to control the Vercise Genus DBS Implantable Pulse Generator (IPG) and External Trial Stimulator (ETS)

Current openFDA PMA Record#

Device: Vercise™ DBS Controller
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S076
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2025-02-05
Decision code: APPR
Date received: 2024-07-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for the Vercise™ DBS Controller, a mobile application intended to function as an alternate to the current Vercise™ Remote Control (RC) 4 (approved in P150031/S034) to control the Vercise Genus DBS Implantable Pulse Generator (IPG) and External Trial Stimulator (ETS)