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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
510(k) Number K091993
Device Name RAPID PROGRAMMER, VERSION 3.3.0
Applicant
ADVANCED NEUROMODULATION SYSTEMS, INC. (ANS INC.)
6901 PRESTON ROAD
PLANO,  TX  75024
Applicant Contact MIA M WARE
Correspondent
ADVANCED NEUROMODULATION SYSTEMS, INC. (ANS INC.)
6901 PRESTON ROAD
PLANO,  TX  75024
Correspondent Contact MIA M WARE
Regulation Number882.5880
Classification Product Code
GZB  
Date Received07/02/2009
Decision Date 07/31/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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