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FDA 510(k) Application Details - K012458
Device Classification Name
Electrode, Pacemaker, Temporary
More FDA Info for this Device
510(K) Number
K012458
Device Name
Electrode, Pacemaker, Temporary
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVENUE NE
MS CW304
MINNEAPOLIS, MN 55432-3576 US
Other 510(k) Applications for this Company
Contact
TINA BENOIT
Other 510(k) Applications for this Contact
Regulation Number
870.3680
More FDA Info for this Regulation Number
Classification Product Code
LDF
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More FDA Info for this Product Code
Date Received
08/01/2001
Decision Date
08/14/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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