FDA Product Code DXY: Implantable Pacemaker Pulse-generator
Leading manufacturers include Medtronic Vascular, Intermedics, Inc. and Telectronics, Inc..
461
Total
461
Cleared
80d
Avg days
1976
Since
FDA 510(k) Cleared Implantable Pacemaker Pulse-generator Devices (Product Code DXY)
461 devices
Cleared
Nov 10, 1999
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
Biotronik, Inc.
Cardiovascular
29d
Cleared
Aug 29, 1997
OPUS S MODEL 4121 AND 4124 PACEMAKERS
Ela Medical, Inc.
Cardiovascular
233d
Cleared
Mar 04, 1996
PIKOS LP 01, PIKOS LP E01
Biotronik, Inc.
Cardiovascular
474d
Cleared
Dec 15, 1995
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
Medtronic Vascular
Cardiovascular
127d
Cleared
Dec 15, 1995
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
Medtronic Vascular
Cardiovascular
127d
Cleared
Sep 29, 1995
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
Biotronik, Inc.
Cardiovascular
134d
Cleared
Sep 01, 1995
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
Ela Medical, Inc.
Cardiovascular
123d
Cleared
Jul 12, 1995
PELLETHANE 75D
Medtronic Vascular
Cardiovascular
554d
Cleared
May 15, 1995
TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES
Medtronic Vascular
Cardiovascular
87d
Cleared
Aug 30, 1994
PIKOS E 01-B
Biotronik, Inc.
Cardiovascular
131d
Cleared
May 02, 1994
MINIX/MINIX ST PULSE GENERATORS
Medtronic Vascular
Cardiovascular
322d
Cleared
May 14, 1993
MEDTRONIC MINIX & MINIX ST PULSE GENERATORS
Medtronic Vascular
Cardiovascular
87d
Cleared
Oct 28, 1992
ASTRA T2, ASTRA T4, ASTRA T6
Cardiac Pacemakers, Inc.
Cardiovascular
260d
Cleared
Mar 17, 1992
INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG
Intermedics, Inc.
Cardiovascular
41d
Cleared
May 16, 1991
8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS
Intermedics, Inc.
Cardiovascular
65d
Cleared
Jan 03, 1991
MEDTRONIC MODEL 5301B TEST CABLE
Medtronic Vascular
Cardiovascular
85d
Cleared
Dec 20, 1990
VACUUM BAKE CYCLE
Medtronic Vascular
Cardiovascular
51d
Cleared
Oct 23, 1990
IMPLANTABLE PULSE DEVICES
Medtronic Vascular
Cardiovascular
60d
Cleared
Jul 03, 1990
MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.
Medtronic Vascular
Cardiovascular
92d
Cleared
Jul 03, 1990
MINIX, MINIX ST, NEW IC: L74
Medtronic Vascular
Cardiovascular
54d
Cleared
Apr 26, 1990
MODIFIED MODEL 5401B TEST CABLE
Medtronic Vascular
Cardiovascular
77d
Cleared
Mar 14, 1990
OPUS MODEL 4021, VVI, 5MM UNIPOLAR
Ela Medical, Inc.
Cardiovascular
42d
Cleared
Jan 26, 1990
MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR
Medtronic Vascular
Cardiovascular
53d
Cleared
Sep 26, 1989
OPUS MODEL 4001
Ela Medical, Inc.
Cardiovascular
110d