TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS

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 Tripole 8c And 16c And Exclaim 8 Lamitrode Series Leads.

Pre-market Notification Details

Device IDK063080
510k NumberK063080
Device Name:TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS
ClassificationStimulator, Spinal-cord, Implanted (pain Relief)
Applicant ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. Plano,  TX  75024
ContactAmy Clendening
CorrespondentAmy Clendening
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 Received2006-10-10
Decision Date2006-12-12

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