FDA Product Code DXY: Implantable Pacemaker Pulse-generator

Cleared Feb 03, 1987

DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS

K862226

Pacesetter Systems

Cardiovascular · 237d

Cleared Jan 12, 1987

EDP-20 PACEMAKER

K860036

Biotronik Sales, Inc.

Cardiovascular · 371d

Cleared Jan 02, 1987

MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE

K862459

Medtronic Vascular

Cardiovascular · 186d

Cleared Dec 10, 1986

TRIOS-M VS-1 PULSE GENERATOR

K863878

Biotronik Sales, Inc.

Cardiovascular · 65d

Cleared Dec 10, 1986

NEOS-M VS-1 PULSE GENERATOR

K863879

Biotronik Sales, Inc.

Cardiovascular · 65d

Cleared Oct 08, 1986

CORDIS MULTICOR II MODEL 402D PACER

K863417

Cordis Corp.

Cardiovascular · 35d

Cleared Oct 08, 1986

MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)

K863582

Cook Pacemaker Corp.

Cardiovascular · 23d

Cleared Sep 24, 1986

MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE

K863418

Intermedics, Inc.

Cardiovascular · 21d

Cleared Sep 04, 1986

ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.

K862974

Medtronic Vascular

Cardiovascular · 29d

Cleared Aug 28, 1986

CERYX PACEMAKER MODELS 114, 314 & 614

K854790

Vitatron Medical BV

Cardiovascular · 272d

Cleared Aug 08, 1986

NEOS VS-1, PULSE GENERATOR

K860921

Biotronik Sales, Inc.

Cardiovascular · 150d

Cleared Aug 04, 1986

MIKROS, MIKROS VS-1, PULSE GENERATOR

K860922

Biotronik Sales, Inc.

Cardiovascular · 146d

Cleared Jul 16, 1986

ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR

K860585

Cardiac Pacemakers, Inc.

Cardiovascular · 148d

Cleared Jul 01, 1986

MODIFIED MODELS 8320/8322/8329/8316/8317/8318

K861719

Medtronic Vascular

Cardiovascular · 60d

Cleared Jun 26, 1986

PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY

K861422

Pacesetter Systems

Cardiovascular · 71d

Cleared Jun 17, 1986

MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN

K862037

Medtronic Vascular

Cardiovascular · 20d

Cleared Jun 17, 1986

MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER

K862038

Medtronic Vascular

Cardiovascular · 20d

Cleared Jun 17, 1986

MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN

K862071

Medtronic Vascular

Cardiovascular · 18d

Cleared May 28, 1986

IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR

K860573

Telectronics, Inc.

Cardiovascular · 103d

Cleared May 09, 1986

SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS

K861559

Cook Pacemaker Corp.

Cardiovascular · 14d

Cleared May 02, 1986

PROGRAMALITH III PULSE GENERATOR

K861140

Pacesetter Systems

Cardiovascular · 37d

Cleared Apr 23, 1986

BIPOLAR CARDIAC PACEMAKER, MODEL 110

K861009

Cardiac Control Systems, Inc.

Cardiovascular · 36d

Cleared Mar 31, 1986

UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762

K852973

Ela Medical, Inc.

Cardiovascular · 259d

Cleared Mar 17, 1986

MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS

K855147

Medtronic Vascular

Cardiovascular · 83d