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FDA 510(k) Application Details - K132008
Device Classification Name
Pacemaker Lead Adaptor
More FDA Info for this Device
510(K) Number
K132008
Device Name
Pacemaker Lead Adaptor
Applicant
MEDTRONIC INC.
8200 CORAL SEA STREET
MOUNDS VIEW, MN 55112 US
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Contact
MICHELE MACHACEK
Other 510(k) Applications for this Contact
Regulation Number
870.3620
More FDA Info for this Regulation Number
Classification Product Code
DTD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/01/2013
Decision Date
07/30/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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