|
Device | Vercise PC and Vercise Gevia Deep Brian Stimulation (DBS) System |
Generic Name | Stimulator, electrical, implanted, for parkinsonian symptoms |
Applicant | Boston Scientific Corp. 25155 Rye Canyon Loop Valencia, CA 91355 |
PMA Number | P150031 |
Supplement Number | S021 |
Date Received | 07/22/2019 |
Decision Date | 10/20/2019 |
Product Code |
NHL |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for minor design changes to the IPG Header in the Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) systems. |