|
Device | Brio Neurostimulation System |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | Abbott Medical 6901 Prestion Road Plano, TX 75024 |
PMA Number | P140009 |
Supplement Number | S051 |
Date Received | 10/21/2019 |
Decision Date | 11/19/2019 |
Product Code |
MHY |
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 Changes in the viable air sampling method and a corresponding change to the action and alert limits for the airborne microbes in the controlled access environments(CAE). |