PMA P150031

Device: Vercise Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S054
Product code: NHL
Decision date: 2026-07-10
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: to add a new controlled environment area (CEA) which is a Class 8 cleanroom, at the Boston Scientific Dorado, Puerto Rico facility for the manufacture of Boston Scientific Neuromodulation (BSN) Spinal Cord Stimulator (SCS) and Deep Brain Stimulation (DBS) Products

Current openFDA PMA Record#

Device: Vercise Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S095
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2026-07-10
Decision code: OK30
Date received: 2026-06-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to add a new controlled environment area (CEA) which is a Class 8 cleanroom, at the Boston Scientific Dorado, Puerto Rico facility for the manufacture of Boston Scientific Neuromodulation (BSN) Spinal Cord Stimulator (SCS) and Deep Brain Stimulation (DBS) Products