|
Device | Vercise 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 | S070 |
Date Received | 02/01/2024 |
Decision Date | 02/26/2024 |
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 that the current supplier of multilayer ceramic capacitors utilize two alternate barrel plating method parameters in the manufacturing process of the capacitors |