FDA 510(k) Applications for Medical Device Product Code: DXY (Implantable Pacemaker Pulse-Generator)

FDA 510(k) Applications for Medical Device Product Code "DXY"
(Implantable Pacemaker Pulse-Generator)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K993434	BIOTRONIK, INC.	PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A	11/10/1999
K945627	BIOTRONIK, INC.	PIKOS LP 01, PIKOS LP E01	03/04/1996
K970072	ELA MEDICAL, INC.	OPUS S MODEL 4121 AND 4124 PACEMAKERS	08/29/1997