|
Device | EON 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 | S059 |
Date Received | 07/17/2012 |
Decision Date | 01/09/2013 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL THE REVISION TO THE MANUFACTURING PROCESS FOR EON MINI (MODEL 3788) IMPLANTABLE PULSE GENERATOR HEADERS. |