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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 K072462
Device Name WIDE SPACED QUATTRODE LEADS
Applicant
Advanced Neuromodulation Systems
6901 Preston Rd.
Plano,  TX  75024
Applicant Contact MIA M WARE
Correspondent
Advanced Neuromodulation Systems
6901 Preston Rd.
Plano,  TX  75024
Correspondent Contact MIA M WARE
Regulation Number882.5880
Classification Product Code
GZB  
Subsequent Product Code
GZF  
Date Received08/31/2007
Decision Date 10/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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