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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 K914433
Device Name MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MINNEAPOLIS,  MN  55432
Applicant Contact DARYLE PETERSEN
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MINNEAPOLIS,  MN  55432
Correspondent Contact DARYLE PETERSEN
Regulation Number882.5880
Classification Product Code
GZB  
Date Received10/04/1991
Decision Date 12/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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