|
Device | EON IMPLANTABLE PULSE GENERATOR |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S057 |
Date Received | 07/06/2012 |
Decision Date | 08/24/2012 |
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 A CHANGE TO THE INTERNAL BATTERY HOUSING MATERIAL FROM TITANIUM TO 304L STAINLESS STEEL. |