FDA 510(k) Application Details - K993434

Device Classification Name	Implantable Pacemaker Pulse-Generator   More FDA Info for this Device
510(K) Number	K993434
Device Name	Implantable Pacemaker Pulse-Generator
Applicant	BIOTRONIK, INC. 6024 JEAN ROAD LAKE OSWEGO, OR 97035 US Other 510(k) Applications for this Company
Contact	Jon Brumbaugh Other 510(k) Applications for this Contact
Regulation Number	870.3610   More FDA Info for this Regulation Number
Classification Product Code	DXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/12/1999
Decision Date	11/10/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review