|
Device | Proclaim family of SCS IPGs |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S168 |
Date Received | 09/09/2020 |
Decision Date | 03/05/2021 |
Product Code |
LGW |
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. |