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FDA 510(k) Application Details - K242705
Device Classification Name
Electrode, Pacemaker, Temporary
More FDA Info for this Device
510(K) Number
K242705
Device Name
Electrode, Pacemaker, Temporary
Applicant
Medtronic Inc
710 Medtronic Parkway
Minneapolis, MN 55432 US
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Contact
Debra Taitague
Other 510(k) Applications for this Contact
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
09/09/2024
Decision Date
01/17/2025
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
FDA Source Information for K242705
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