|
Device | EON IMPLANTABLE PULSE GENERATOR (IPG) NEUROSTIMULATION 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 | S032 |
Date Received | 07/15/2009 |
Decision Date | 04/08/2010 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE INCORPORATION OF A COLOR ADDITIVE TO CHANGE THE COLOR OF THE POCKET SIZER TO YELLOW, SO THAT IT WOULD BE MORE EASILY VISIBLE TO THE PHYSICIAN. |