PMA P150031S041

Device: Deep Brain Stimulation (DBS) Systems - Vercise PC, Gevia and Genus Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S041
Product code: NHL
Decision date: 2021-04-23
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: Addition of two new reflow ovens to the manufacturing process for the Printed Circuit Board Assemblies (PCBAs) of the Implantable Pulse Generator (IPG) and External Trial Stimulator (ETS).

Current openFDA PMA Record#

Device: Deep Brain Stimulation (DBS) Systems - Vercise PC, Gevia and Genus Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S041
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2021-04-23
Decision code: OK30
Date received: 2021-04-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of two new reflow ovens to the manufacturing process for the Printed Circuit Board Assemblies (PCBAs) of the Implantable Pulse Generator (IPG) and External Trial Stimulator (ETS).