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EON NEUROSTIMULATION SYSTEM, EON MINI NEUROSTIMULATION SYSTEM, 3788 AND EON NEUROSTIMULATION SYSTEM, 3688

FDA premarket approval P010032/S063 · decided 2013-04-11

Approval details

PMA number
P010032
Supplement
S063
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
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
Date received
2012-10-15
Decision date
2013-04-11
Days to decision
178 days
Decision code
APPR
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Plano, TX
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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