FDA 510(k) Application Details - K162054

Device Classification Name	Pulse-Generator, Pacemaker, External   More FDA Info for this Device
510(K) Number	K162054
Device Name	Pulse-Generator, Pacemaker, External
Applicant	MEDTRONIC, INC. 8200 CORAL SEA STREET NE MOUNDS VIEW, MN 55112 US Other 510(k) Applications for this Company
Contact	SYED SUMRAN MOHIUDDIN Other 510(k) Applications for this Contact
Regulation Number	870.3600   More FDA Info for this Regulation Number
Classification Product Code	DTE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2016
Decision Date	10/18/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review