PMA P150031S087

Device: Vercise Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S087
Product code: NHL
Decision date: 2025-09-19
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: the qualification of an alternate supplier, AVNA, for the IPG Pocket Template used with the Boston Scientific Neuromodulation Spinal Cord Stimulator and Deep Brain Stimulation Implantable Pulse Generators (IPGs). Additionally, the alternate supplier is changing the manufacturing process for the IPG Pocket Templates from chemical etching to metal stamping and laser etching

Current openFDA PMA Record#

Device: Vercise Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S087
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2025-09-19
Decision code: OK30
Date received: 2025-08-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the qualification of an alternate supplier, AVNA, for the IPG Pocket Template used with the Boston Scientific Neuromodulation Spinal Cord Stimulator and Deep Brain Stimulation Implantable Pulse Generators (IPGs). Additionally, the alternate supplier is changing the manufacturing process for the IPG Pocket Templates from chemical etching to metal stamping and laser etching