PMA P150031S070

Device: Vercise Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S070
Product code: NHL
Decision date: 2024-02-26
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: that the current supplier of multilayer ceramic capacitors utilize two alternate barrel plating method parameters in the manufacturing process of the capacitors

Current openFDA PMA Record#

Device: Vercise Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S070
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2024-02-26
Decision code: OK30
Date received: 2024-02-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: that the current supplier of multilayer ceramic capacitors utilize two alternate barrel plating method parameters in the manufacturing process of the capacitors