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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Peripheral Nerve, Implanted (Pain Relief)
510(k) Number K904409
Device Name MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER
Applicant
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Applicant Contact LINDA S ALEXANDER
Correspondent
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Correspondent Contact LINDA S ALEXANDER
Regulation Number882.5870
Classification Product Code
GZF  
Date Received09/26/1990
Decision Date 01/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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