FDA 510(k) Application Details - K961679

Device Classification Name Permanent Pacemaker Electrode

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510(K) Number K961679
Device Name Permanent Pacemaker Electrode
Applicant MEDTRONIC VASCULAR
7000 CENTRAL AVENUE, N.E.
MINNEAPOLIS, MN 55432-3576 US
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Contact NORA K HADDING
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Regulation Number 870.3680

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Classification Product Code DTB
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Date Received 05/01/1996
Decision Date 07/30/1996
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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