DXY · Class III · 21 CFR 870.3610

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
461 devices
73–96 of 461
Cleared Jan 22, 1986
TELEMETRY WAND MODEL
K855171
Cardiac Pacemakers, Inc.
Cardiovascular · 27d
Cleared Jan 16, 1986
IMPLANTABLE PROGRAMMABLE PULSE GENERATOR
K854560
Telectronics, Inc.
Cardiovascular · 63d
Cleared Jan 14, 1986
CORDIS MULTICOR ST, MODEL 350A
K851968
Cordis Corp.
Cardiovascular · 252d
Cleared Jan 07, 1986
PROGRAMALITH III MODELS 238 & 239
K854195
Pacesetter Systems
Cardiovascular · 84d
Cleared Dec 03, 1985
MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE
K854214
Cordis Corp.
Cardiovascular · 47d
Cleared Nov 08, 1985
SUPRIMA MODEL 254-22
K852339
Intermedics, Inc.
Cardiovascular · 158d
Cleared Nov 08, 1985
SUPRIMA MODEL 254-24
K852340
Intermedics, Inc.
Cardiovascular · 158d
Cleared Nov 01, 1985
MEDTRONICS MODELS 8320/8322/8329
K852688
Medtronic Vascular
Cardiovascular · 129d
Cleared Nov 01, 1985
CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK
K852748
Cordis Corp.
Cardiovascular · 127d
Cleared Nov 01, 1985
BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS
K854143
Telectronics, Inc.
Cardiovascular · 21d
Cleared Sep 13, 1985
NEOS - M ABP
K853058
Biotronik Sales, Inc.
Cardiovascular · 56d
Cleared Sep 12, 1985
TRIOS - M
K853057
Biotronik Sales, Inc.
Cardiovascular · 55d
Cleared Sep 12, 1985
IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW
K853206
Telectronics, Inc.
Cardiovascular · 43d
Cleared Jul 25, 1985
ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251
K853017
Ela Medical, Inc.
Cardiovascular · 8d
Cleared Jul 25, 1985
#335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ
K853034
Intermedics, Inc.
Cardiovascular · 7d
Cleared Jul 19, 1985
SUPRIMA II MODEL 254-26
K852431
Intermedics, Inc.
Cardiovascular · 39d
Cleared Jul 17, 1985
SUPRIMA II MODEL 253-23
K852430
Intermedics, Inc.
Cardiovascular · 37d
Cleared Jul 17, 1985
SUPRIMA II MODEL 254-28
K852432
Intermedics, Inc.
Cardiovascular · 37d
Cleared Jun 21, 1985
MULTICOR S, MODELS 330A/331A
K851420
Cordis Corp.
Cardiovascular · 73d
Cleared Jun 18, 1985
CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS
K844360
Cordis Corp.
Cardiovascular · 217d
Cleared Jun 11, 1985
STANICOR GAMMA 333B/334A
K851416
Cordis Corp.
Cardiovascular · 63d
Cleared Jun 11, 1985
MULTICOR GAMMA MODELS 336/337
K851417
Cordis Corp.
Cardiovascular · 63d
Cleared Jun 11, 1985
OMNI-ATRICOR MODEL 308A
K851418
Cordis Corp.
Cardiovascular · 63d
Cleared Jun 11, 1985
MULTICOR GAMMA 402 SERIES PACER
K851419
Cordis Corp.
Cardiovascular · 63d