|
Device | Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems |
Generic Name | Stimulator, electrical, implanted, for parkinsonian symptoms |
Applicant | Boston Scientific Corp. 25155 Rye Canyon Loop Valencia, CA 91355 |
PMA Number | P150031 |
Supplement Number | S024 |
Date Received | 08/26/2019 |
Decision Date | 09/24/2019 |
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 Statistical Process Monitoring and Control (SPC)-based sampling plan to be used for in-process monitoring of validated processes at the Boston Scientific Neuromodulation (BSN) manufacturing sites. |