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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 K102523
Device Name MULTI-LEAD TRIALING CABLE MODEL 355531
Applicant
Medtronic, Inc.
7000 Central Ave., NE
Minneapolis,  MN  55432
Applicant Contact TRISHIA DWYER
Correspondent
Medtronic, Inc.
7000 Central Ave., NE
Minneapolis,  MN  55432
Correspondent Contact TRISHIA DWYER
Regulation Number882.5880
Classification Product Code
GZB  
Subsequent Product Code
GZF  
Date Received09/02/2010
Decision Date 10/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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