FDA 510(k) Application Details - K152784

Device Classification Name	Electrode, Pacemaker, Temporary   More FDA Info for this Device
510(K) Number	K152784
Device Name	Electrode, Pacemaker, Temporary
Applicant	ST. JUDE MEDICAL 14901 DEVEAU PLACE MINNETONKA, MN 55345 US Other 510(k) Applications for this Company
Contact	PARITA MEHTA 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	09/25/2015
Decision Date	10/22/2015
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