TRIAL CABLE, 3009

Stimulator, Spinal-cord, Implanted (pain Relief)

ADVANCED NEUROMODULATION SYSTEMS

The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Trial Cable, 3009.

Pre-market Notification Details

Device IDK070847
510k NumberK070847
Device Name:TRIAL CABLE, 3009
ClassificationStimulator, Spinal-cord, Implanted (pain Relief)
Applicant ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. Plano,  TX  75024
ContactPenny Houston
CorrespondentPenny Houston
ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. Plano,  TX  75024
Product CodeGZB  
CFR Regulation Number882.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-28
Decision Date2007-04-11

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