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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 K933055
Device Name MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF
Applicant
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Applicant Contact BECKY L SAVAGEAU
Correspondent
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Correspondent Contact BECKY L SAVAGEAU
Regulation Number870.3680
Classification Product Code
DTB  
Date Received05/27/1993
Decision Date 05/02/1994
Decision SE SUBJECT TO TRAKING & PMS (PT)
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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