FDA 510(k) Application Details - K965106

Device Classification Name	Permanent Pacemaker Electrode   More FDA Info for this Device
510(K) Number	K965106
Device Name	Permanent Pacemaker Electrode
Applicant	BIOTRONIK, INC. 6024 JEAN ROAD LAKE OSWEGO, OR 97035 US Other 510(k) Applications for this Company
Contact	Joseph J Schwoebel 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	12/20/1996
Decision Date	01/27/1998
Decision	PT - Substantially Equivalent - Subject to Tracking & PMS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review