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 NEUROSTIMULATION SYSTEM, EON MINI NEUROSTIMULATION SYSTEM, 3788 AND EON NEUROSTIMULATION SYSTEM, 3688 |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S063 |
Date Received | 10/15/2012 |
Decision Date | 04/11/2013 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REPLACING THE CURRENT CONTRAINDICATION REGARDING USE OF THENEUROSTIMULATOR IN PATIENTS WITH DEMAND-TYPE CARDIAC PACEMAKERS WITH A WARNING STATEMENT THAT RECOMMENDS INTERACTION TESTING AND AVOIDING UNIPOLAR PROGRAMMING OF THE NEUROSTIMULATOR. |
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