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FDA 510(k) Application Details - K040812
Device Classification Name
Electrode, Pacemaker, Temporary
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.3680
More FDA Info for this Regulation Number
Classification Product Code
LDF
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More FDA Info for this Product Code
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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