FDA 510(k) Application Details - K031274

Device Classification Name Permanent Pacemaker Electrode

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510(K) Number K031274
Device Name Permanent Pacemaker Electrode
Applicant MEDTRONIC VASCULAR
7000 CENTRAL AVENUE NE
MS CW304
MINNEAPOLIS, MN 55432-3576 US
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Contact TINA BENOIT
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Regulation Number 870.3680

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Classification Product Code DTB
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Date Received 04/22/2003
Decision Date 05/22/2003
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Special
Reviewed By Third Party N
Expedited Review



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