|
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 | S156 |
Date Received | 11/08/2019 |
Decision Date | 06/05/2020 |
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 cybersecurity software updates for the Clinician Programmer (CP) and Patient Controller (PC). |