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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K903919
Device Name IMPLANTABLE PULSE DEVICES
Applicant
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Applicant Contact LYNN NORDSTROM
Correspondent
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Correspondent Contact LYNN NORDSTROM
Regulation Number870.3610
Classification Product Code
DXY  
Date Received08/24/1990
Decision Date 10/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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