FDA 510(k) Application Details - K980869

Device Classification Name	Permanent Pacemaker Electrode   More FDA Info for this Device
510(K) Number	K980869
Device Name	Permanent Pacemaker Electrode
Applicant	BIOTRONIK, INC. 6024 JEAN ROAD LAKE OSWEGO, OR 97035 US Other 510(k) Applications for this Company
Contact	DAVID MAKANANI 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	03/06/1998
Decision Date	09/10/1998
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