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FDA 510(k) Application Details - K961679
Device Classification Name
Permanent Pacemaker Electrode
More FDA Info for this Device
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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More FDA Info for this Product Code
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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