FDA 510(k) Application Details - K152633

Device Classification Name	Electrode, Pacemaker, Temporary   More FDA Info for this Device
510(K) Number	K152633
Device Name	Electrode, Pacemaker, Temporary
Applicant	EDWARDS LIFESCIENCES, LLC ONE EDWARDS WAY IRVINE, CA 92614 US Other 510(k) Applications for this Company
Contact	DEANA BOUSHELL 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	09/15/2015
Decision Date	10/15/2015
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