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 Other 510(k) Applications for this Company
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