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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 K884215
Device Name MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331
Applicant
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Applicant Contact H MORRISSEY
Correspondent
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Correspondent Contact H MORRISSEY
Regulation Number870.3610
Classification Product Code
DXY  
Date Received10/06/1988
Decision Date 11/17/1988
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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