|
Device | GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S115 |
Date Received | 03/21/2016 |
Decision Date | 10/18/2016 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a Magnetic Resonance labeling change to allow full-body MRI scans under defined conditions. |