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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 K951858
Device Name TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS
Applicant
Medtronic Vascular
7000 Central Ave. NE
Minneapolis,  MN  55432 -3576
Applicant Contact VICKI PEARSON
Correspondent
Medtronic Vascular
7000 Central Ave. NE
Minneapolis,  MN  55432 -3576
Correspondent Contact VICKI PEARSON
Regulation Number870.3680
Classification Product Code
DTB  
Date Received04/21/1995
Decision Date 10/12/1995
Decision SE SUBJECT TO TRACKING REG (ST)
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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