PMA P150031S069

Device: Vercise Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S069
Product code: NHL
Decision date: 2024-01-09
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: approval for the qualification of an alternate supplier, Integer, for the Proximal Contact and Distal Electrode components used in Boston Scientific Neuromodulation Spinal Cord Stimulator and Deep Brain Stimulation Leads and Lead Products (Extensions, Splitters, Adapters, and Connectors)

Current openFDA PMA Record#

Device: Vercise Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S069
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2024-01-09
Decision code: OK30
Date received: 2023-12-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the qualification of an alternate supplier, Integer, for the Proximal Contact and Distal Electrode components used in Boston Scientific Neuromodulation Spinal Cord Stimulator and Deep Brain Stimulation Leads and Lead Products (Extensions, Splitters, Adapters, and Connectors)