FDA 510(k) Application Details - K242705

Device Classification Name Electrode, Pacemaker, Temporary

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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
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Regulation Number 870.3680

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Classification Product Code LDF
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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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