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FDA 510(k) Application Details - K140972
Device Classification Name
Electrode, Pacemaker, Temporary
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510(K) Number
K140972
Device Name
Electrode, Pacemaker, Temporary
Applicant
MEDTRONIC, INC.
1851 EAST DEERE AVE.
SANTA ANA, CA 92705 US
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Contact
DEBRA TAITAGUE
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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
04/16/2014
Decision Date
06/06/2014
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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