|
Device | EON AND GENESIS RC NEUROSTIMULATION 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 | S019 |
Date Received | 01/23/2006 |
Decision Date | 12/13/2007 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR INCREASING THE BATTERY LONGEVITY CLAIM FOR SEVEN YEARS TO 10 YEARS. |