FDA 510(k) Application Details - K190716

Device Classification Name	Electrode, Pacemaker, Temporary   More FDA Info for this Device
510(K) Number	K190716
Device Name	Electrode, Pacemaker, Temporary
Applicant	Medtronic 1851 East Deere Ave. Santa Ana, CA 92705 US Other 510(k) Applications for this Company
Contact	Joven Almazan 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	03/19/2019
Decision Date	08/08/2019
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