Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | EON MINI 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 | S058 |
Date Received | 07/16/2012 |
Decision Date | 09/14/2012 |
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 THE MODIFICATION TO THE MODEL 3721 EON MINI CHARGINGSYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MODEL 3720 EON MINI LE CHARGER AND MODEL 3722 EON MINI LE CHARGING SYSTEM AND IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL PAIN ASSOCIATED WITH ANY OF THE FOLLOWING: FAILED BACK SURGERY SYNDROME, AND CHRONIC LOW BACK/LEG PAIN. |
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