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
97–120 of 461
Cleared Mar 07, 1986
PHOENIX MODELS 250/251 PULSE GENERATORS
K855081
Pacesetter Systems
Cardiovascular · 78d
Cleared Feb 28, 1986
ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS
K854482
Medtronic Vascular
Cardiovascular · 113d
Cleared Feb 24, 1986
CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK
K853400
Cardiac Control Systems, Inc.
Cardiovascular · 199d
Cleared Feb 24, 1986
CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA
K853471
Cardiac Control Systems, Inc.
Cardiovascular · 189d
Cleared Feb 24, 1986
MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER.
K860202
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Feb 24, 1986
MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.
K860466
Cook Pacemaker Corp.
Cardiovascular · 18d
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 14, 1986
ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER
K852641
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 208d
Cleared Jan 07, 1986
PROGRAMALITH III MODELS 238 & 239
K854195
Pacesetter Systems
Cardiovascular · 84d
Cleared Dec 19, 1985
BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY
K854919
Cook Pacemaker Corp.
Cardiovascular · 10d
Cleared Dec 03, 1985
SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM
K851365
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 242d
Cleared Dec 03, 1985
COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS
K854132
Cook Pacemaker Corp.
Cardiovascular · 54d
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 Oct 23, 1985
COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI
K853590
Cook Pacemaker Corp.
Cardiovascular · 56d
Cleared Oct 23, 1985
COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER
K853651
Cook Pacemaker Corp.
Cardiovascular · 50d
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