Biotronik Sales, Inc.

FDA 510(k) & PMA Approved Devices — 41 products

Total Devices41

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K875199	NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR	DTB	1988-02-18	View
510(k)	K853194	ERA-20	DTE	1987-03-11	View
510(k)	K860036	EDP-20 PACEMAKER	DXY	1987-01-12	View
510(k)	K863878	TRIOS-M VS-1 PULSE GENERATOR	DXY	1986-12-10	View
510(k)	K863879	NEOS-M VS-1 PULSE GENERATOR	DXY	1986-12-10	View
510(k)	K863480	BIOTRONIK PERMANENT PACEMAKER ELECTRODE	DTB	1986-09-23	View
510(k)	K860921	NEOS VS-1, PULSE GENERATOR	DXY	1986-08-08	View
510(k)	K860922	MIKROS, MIKROS VS-1, PULSE GENERATOR	DXY	1986-08-04	View
510(k)	K853566	DJ UNIPOLAR	DTB	1986-05-07	View
510(k)	K853567	DJP UNIPOLAR	DTB	1986-05-07	View
510(k)	K853568	DNR UNIPOLAR	DTB	1986-01-15	View
510(k)	K853058	NEOS - M ABP	DXY	1985-09-13	View
510(k)	K853057	TRIOS - M	DXY	1985-09-12	View
510(k)	K844842	NEOS-LP PULSE GENERATOR	DXY	1985-04-18	View
510(k)	K844841	KALOS-04 PULSE GENERATOR	DXY	1985-04-18	View
510(k)	K844795	NEOS-M PULSE GENERATOR	DXY	1985-04-18	View
510(k)	K844812	NEOS - PULSE GENERATOR	DXY	1985-04-18	View
510(k)	K844794	LEPTOS PULSE GENERATOR	DXY	1985-04-18	View
510(k)	K841451	BIOTRONIK DY-UNIPOLAR	DTD	1985-02-07	View
510(k)	K841450	BIOTRONIK DNP UNIPOLAR	DTD	1985-02-07	View