|
Device | Vercise Deep Brain 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 | S008 |
Date Received | 07/23/2018 |
Decision Date | 08/22/2018 |
Product Code |
NHL |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Use of the E84273-100 Tube Ablation System for the ablation process for multi-lumen tubes that are used in the assembly of 8 Contact Extension Lead (55 cm) and Vercise M8 Adapters (15cm and 55cm) at the Boston Scientific Puerto Rico manufacturing facility. |