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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Permanent Pacemaker Electrode
510(k) Number K031274
Device Name MODEL 5071 MYOCARDIAL PACING LEAD
Applicant
Medtronic Vascular
7000 Central Ave. NE
Ms Cw 304
Minneapolis,  MN  55432
Applicant Contact TINA BENOIT
Correspondent
Medtronic Vascular
7000 Central Ave. NE
Ms Cw 304
Minneapolis,  MN  55432
Correspondent Contact TINA BENOIT
Regulation Number870.3680
Classification Product Code
DTB  
Date Received04/22/2003
Decision Date 05/22/2003
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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