|
Device | EON CTM 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 | S076 |
Date Received | 01/10/2014 |
Decision Date | 04/25/2014 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement VAPPROVAL FOR PACKAGING MODIFICATIONS TO REMOVE THE MODEL 3009 TRIAL CABLE FROM APPROVED SJM LEADS AND EXTENSIONS. |