FDA 510(k) Application Details - K972574

Device Classification Name	Permanent Pacemaker Electrode   More FDA Info for this Device
510(K) Number	K972574
Device Name	Permanent Pacemaker Electrode
Applicant	ELA MEDICAL, INC. 2950 XENIUM LN. NORTH PLYMOUTH, MN 55441 US Other 510(k) Applications for this Company
Contact	CATHERINE G GOBLE Other 510(k) Applications for this Contact
Regulation Number	870.3680   More FDA Info for this Regulation Number
Classification Product Code	DTB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/1997
Decision Date	01/08/1998
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review