|
Device | GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S093 |
Date Received | 12/24/2014 |
Decision Date | 07/06/2015 |
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 1) ADDITION OF THE PENTA LEAD TO THE PROTÉGÉ MRI NEUROSTIMULATION SYSTEM AND RELATED LABELING CHANGES; AND 2) REMOVAL OF A WARNING CONCERNING A PATIENT WITH A FEVER UNDERGOING AN MRI SCAN. |