FDA Product Code DXY: Implantable Pacemaker Pulse-generator
Leading manufacturers include Medtronic Vascular, Intermedics, Inc. and Cordis Corp..
461
Total
461
Cleared
80d
Avg days
1976
Since
FDA 510(k) Cleared Implantable Pacemaker Pulse-generator Devices (Product Code DXY)
461 devices
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
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
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
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
Jan 26, 1990
MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR
Medtronic Vascular
Cardiovascular
53d
Cleared
Sep 26, 1989
ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS
Medtronic Vascular
Cardiovascular
29d
Cleared
Aug 25, 1989
MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS
Medtronic Vascular
Cardiovascular
79d
Cleared
Nov 17, 1988
MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS
Medtronic Vascular
Cardiovascular
76d
Cleared
Nov 17, 1988
MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331
Medtronic Vascular
Cardiovascular
42d
Cleared
Nov 23, 1987
QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.
Intermedics, Inc.
Cardiovascular
26d
Cleared
Oct 09, 1987
MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS
Intermedics, Inc.
Cardiovascular
38d
Cleared
Aug 10, 1987
MEDTRONIC CLASSIX MODELS 8436/8437/8438
Medtronic Vascular
Cardiovascular
89d
Cleared
Jan 02, 1987
MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE
Medtronic Vascular
Cardiovascular
186d
Cleared
Oct 08, 1986
CORDIS MULTICOR II MODEL 402D PACER
Cordis Corp.
Cardiovascular
35d