PMA P150031S086

Device: VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S086
Product code: NHL
Decision date: 2025-06-25
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: approval for an alternate Sterilization Cycle (BSC120), to sterilize all Deep Brain Stimulation (DBS) and Spinal Cord Stimulator (SCS) Implantable Pulse Generators (IPGs) manufactured at the BSC Clonmel (CLN) site, County Tipperary, Ireland

Current openFDA PMA Record#

Device: VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S086
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2025-06-25
Decision code: OK30
Date received: 2025-05-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for an alternate Sterilization Cycle (BSC120), to sterilize all Deep Brain Stimulation (DBS) and Spinal Cord Stimulator (SCS) Implantable Pulse Generators (IPGs) manufactured at the BSC Clonmel (CLN) site, County Tipperary, Ireland