FDA 510(k) Application Details - K945627

Device Classification Name	Implantable Pacemaker Pulse-Generator   More FDA Info for this Device
510(K) Number	K945627
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	LAUREN L FOOTE CHRISTENSEN 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	11/16/1994
Decision Date	03/04/1996
Decision	SESP - SE - POSTMARKET SURVEILLANCE REQUIRED
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review