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
385–408 of 461
Cleared Apr 25, 1977
GENERATOR, PULSE, BIPOLAR, MODEL #604
K770715
Cardiac Pacemakers, Inc.
Cardiovascular · 7d
Cleared Apr 05, 1977
CENTURION
K770419
Johnson & Johnson Professionals, Inc.
Cardiovascular · 32d
Cleared Feb 07, 1977
UNIPOLAR, ASYNCHRONOUS PULSE GENERATOR
K770197
Cardiac Pacemakers, Inc.
Cardiovascular · 7d
Cleared Feb 07, 1977
BIPOLAR ASYNCHRONOUS PULSE GENERATOR
K770198
Cardiac Pacemakers, Inc.
Cardiovascular · 7d
Cleared Dec 23, 1976
LITHIUM IODIDE BATTERY PACEMAKER (#201)
K761143
Pacesetter Systems
Cardiovascular · 27d
Cleared Dec 21, 1976
ELEC. CIR. PACE. MO. LI-2,LI-3,LI-4,LI-5
K761237
Arco Medical Products Co.
Cardiovascular · 8d
Cleared Nov 12, 1976
PACEMAKERS, VITATRON'S
K760669
Vitatron Medical BV
Cardiovascular · 56d
Cleared Nov 12, 1976
PACEMAKERS, VITATRONS (SERIES 2000)
K760670
Vitatron Medical BV
Cardiovascular · 56d
Cleared Nov 12, 1976
PACEMAKERS, VITATRONS (SERIES 3000)
K760671
Vitatron Medical BV
Cardiovascular · 56d
Cleared Nov 11, 1976
MODEL 100 CARDIAC PACEMAKER
K760757
Pacesetter Systems
Cardiovascular · 41d