FDA 510(k) Application Details - K971474

Device Classification Name	Pulse-Generator, Pacemaker, External   More FDA Info for this Device
510(K) Number	K971474
Device Name	Pulse-Generator, Pacemaker, External
Applicant	MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE MINNEAPOLIS, MN 55432-3576 US Other 510(k) Applications for this Company
Contact	LORNA J HARMUTH 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	04/23/1997
Decision Date	07/14/1997
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