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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 K953866
Device Name MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVE. NE
MINNEAPOLIS,  MN  55432 -3576
Applicant Contact DENNIS CONNOLLY
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVE. NE
MINNEAPOLIS,  MN  55432 -3576
Correspondent Contact DENNIS CONNOLLY
Regulation Number870.3610
Classification Product Code
DXY  
Date Received08/10/1995
Decision Date 12/15/1995
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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