FDA 510(k) Application Details - K012454

Device Classification Name	Electrode, Pacemaker, Temporary   More FDA Info for this Device
510(K) Number	K012454
Device Name	Electrode, Pacemaker, Temporary
Applicant	MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 MINNEAPOLIS, MN 55432-3576 US Other 510(k) Applications for this Company
Contact	TINA BENOIT Other 510(k) Applications for this Contact
Regulation Number	870.3680   More FDA Info for this Regulation Number
Classification Product Code	LDF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2001
Decision Date	08/14/2001
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