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FDA 510(k) Application Details - K963898
Device Classification Name
Electrode, Pacemaker, Temporary
More FDA Info for this Device
510(K) Number
K963898
Device Name
Electrode, Pacemaker, Temporary
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVE. NE
MINNEAPOLIS, MN 55432-3576 US
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Contact
SUSAN NODDIN
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Regulation Number
870.3680
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Classification Product Code
LDF
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More FDA Info for this Product Code
Date Received
09/27/1996
Decision Date
07/22/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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