PMA P150031S053

Device: Vercise Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S053
Product code: NHL
Decision date: 2022-12-17
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: Introduce an optional weld cycle (reweld) to the Weld Case and Feedthru Laser Weld Implantable Pulse Generators process step at its Clonmel Ireland manufacturing facility.

Current openFDA PMA Record#

Device: Vercise Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S053
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2022-12-17
Decision code: OK30
Date received: 2022-12-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Introduce an optional weld cycle (reweld) to the Weld Case and Feedthru Laser Weld Implantable Pulse Generators process step at its Clonmel Ireland manufacturing facility.