|
Device | Infinity family of DBS IPGs |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | Abbott Medical 6901 Prestion Road Plano, TX 75024 |
PMA Number | P140009 |
Supplement Number | S064 |
Date Received | 09/09/2020 |
Decision Date | 03/05/2021 |
Product Codes |
MHY NHL PJS |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an update to the Clinician Programmer Application and Patient Controller Application to version 202.0 to include a Remote Care feature that facilitates remote communication between the Clinician Programmer Application and Patient Programmer Application. |