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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 K915540
Device Name MODEL 3587A RESUME II LEAD
Applicant
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Applicant Contact DARYLE PETERSEN
Correspondent
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Correspondent Contact DARYLE PETERSEN
Regulation Number882.5870
Classification Product Code
GZF  
Date Received12/10/1991
Decision Date 01/22/1992
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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