Medical Device Manufacturer · US , Mchenry , IL

Pacesetter Systems - FDA 510(k) Cleared Devices

96 submissions · 96 cleared · Since 1976

96

Total

96

Cleared

0

Denied

87 devices

26-50 of 87

Cleared Dec 04, 1985

PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD

Cardiovascular · 33d

Cleared Dec 03, 1985

PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI

Cardiovascular · 71d

Cleared May 21, 1985

PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE

Cardiovascular · 29d

Cleared May 16, 1985

PROGRAMALITH III MODEL 249 PULSE GENERATOR

Cardiovascular · 20d

Cleared May 15, 1985

PROGRAMALITH III 240 PULSE GENERATOR

Cardiovascular · 97d

Cleared Apr 19, 1985

PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD

Cardiovascular · 29d

Cleared Apr 10, 1985

PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD

Cardiovascular · 50d

Cleared Apr 01, 1985

PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR

Cardiovascular · 41d

Cleared Mar 06, 1985

PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR

Cardiovascular · 21d

Cleared Feb 14, 1985

PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD

Cardiovascular · 62d

Cleared Jan 10, 1985

VIVALITH II 301 PULSE GENERATOR

Cardiovascular · 64d

Cleared Jan 08, 1985

PERMATHANE 865 & 867 UNIPOLAR POLYURETH

Cardiovascular · 109d

Cleared Aug 03, 1984

MODEL 866 PERMATHANE BIPOLAR, COAXIAL

Cardiovascular · 98d

Cleared Aug 03, 1984

FASTPASS IMPLANTABLE ENDOCARDIAL PAC

Cardiovascular · 88d

Cleared Mar 12, 1984

PACING ELECTRODE

Cardiovascular · 87d

Cleared Dec 21, 1983

VASCUTEK VASCULAR PROTHESIS VP1200K/50K

Cardiovascular · 352d

Cleared Dec 16, 1983

PACEMAKER SYS ANALYZER #384

Cardiovascular · 60d

Cleared Dec 01, 1983

ENDOCARDIAL SCREW-IN LEAD 859 & 861

Cardiovascular · 31d

Cleared Oct 20, 1983

PERMANTHANE #866 BIPOLAR COAXIAL

Cardiovascular · 49d

Cleared Aug 12, 1983

PACELINE PATIENT TRANSMITTER MODEL 324

Cardiovascular · 99d

Cleared Jun 08, 1983

VENTRICULAR PACING LEADS MODELS 865/867

Cardiovascular · 35d

Cleared Jun 08, 1983

UNIPOLAR ATRIAL J PACING LEAD MODEL 869

Cardiovascular · 35d

Cleared Mar 24, 1983

IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242

Cardiovascular · 87d

Cleared Feb 18, 1983

AFP SYSTEM PULSE GENERATOR MODEL 261/262

Cardiovascular · 170d

Cleared Feb 18, 1983

AFP PULSE GENERATOR

Cardiovascular · 78d

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