FDA 510(k) Application Details - K000763

Device Classification Name	Permanent Pacemaker Electrode   More FDA Info for this Device
510(K) Number	K000763
Device Name	Permanent Pacemaker Electrode
Applicant	BIOTRONIK, GMBH & CO. 6024 JEAN RD. LAKE OSWEGO, OR 97035 US Other 510(k) Applications for this Company
Contact	Jon Brumbaugh 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	03/09/2000
Decision Date	04/06/2000
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Special
Reviewed By Third Party	N
Expedited Review