FDA 510(k) Application Details - K040812

Device Classification Name Electrode, Pacemaker, Temporary

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510(K) Number K040812
Device Name Electrode, Pacemaker, Temporary
Applicant MEDTRONIC VASCULAR
1015 GRAMSIE RD
SHOREVIEW, MN 55126-3082 US
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Contact EDWARD VALDEZ
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Regulation Number 870.3680

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Classification Product Code LDF
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Date Received 03/29/2004
Decision Date 09/02/2004
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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