Pacesetter Systems

FDA Filings

This page includes the latest FDA filings for Pacesetter Systems. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
PACESETTER SYSTEMS
 CARBON TIP CARDIAC PACING LEAD1996-01-04
PACESETTER SYSTEMS
 CARBON TIP CARDIAC PACING LEAD1994-10-17
PACESETTER SYSTEMS
 CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K1994-05-25
PACESETTER SYSTEMS
 CARBON TIPPED LEAD ALT.PROD.TRAYS1992-11-18
PACESETTER SYSTEMS
ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE1991-08-28
PACESETTER SYSTEMS
 CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K1990-12-18
PACESETTER SYSTEMS
 CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K1990-12-10
PACESETTER SYSTEMS
ENDOCARDIAL SCREW-IN LEAD MODEL 1028T1990-07-17
PACESETTER SYSTEMS
SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS1990-06-25
PACESETTER SYSTEMS
FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T1990-04-20
PACESETTER SYSTEMS
ENDOCARDIAL SCREW-IN LEAD MODEL 1020T1989-12-20
PACESETTER SYSTEMS
 ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP1989-06-19
PACESETTER SYSTEMS
CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE1989-06-05
PACESETTER SYSTEMS
VS-1 MODEL NUMBER 251K PULSE GENERATOR1989-03-28
PACESETTER SYSTEMS
SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS1989-03-22
PACESETTER SYSTEMS
AFP MODEL 262T PULSE GENERATOR1989-02-10
PACESETTER SYSTEMS
PROLOG MP 658M PULSE GENERATOR1988-09-14
PACESETTER SYSTEMS
ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T1988-02-02
PACESETTER SYSTEMS
PROLOG MP PULSE GENERATORS 658K AND 658T1987-11-04
PACESETTER SYSTEMS
MODIFIED MODELS 1025M & 1026T PACING LEAD1987-10-22
PACESETTER SYSTEMS
 ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP1987-06-22
PACESETTER SYSTEMS
UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M1987-06-05
PACESETTER SYSTEMS
ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 10351987-03-20
PACESETTER SYSTEMS
DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS1987-02-03
PACESETTER SYSTEMS
 ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP1986-09-02
PACESETTER SYSTEMS
 DDD PULSE GENERATOR 6741986-07-31
PACESETTER SYSTEMS
PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY1986-06-26
PACESETTER SYSTEMS
SOF SET, MODELS 111 AND 1121986-06-09
PACESETTER SYSTEMS
ENDOCARDIAL CARBON-TIP LEAD1986-06-06
PACESETTER SYSTEMS
SOF SET, MODELS 113 AND 1141986-05-27
PACESETTER SYSTEMS
LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS1986-05-19
PACESETTER SYSTEMS
LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO1986-05-13
PACESETTER SYSTEMS
PROGRAMALITH III PULSE GENERATOR1986-05-02
PACESETTER SYSTEMS
DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.371986-04-23
PACESETTER SYSTEMS
PHOENIX MODELS 250/251 PULSE GENERATORS1986-03-07
PACESETTER SYSTEMS
 ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP1986-02-12
PACESETTER SYSTEMS
PROGRAMALITH III MODELS 238 & 2391986-01-07
PACESETTER SYSTEMS
PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD1985-12-04
PACESETTER SYSTEMS
PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD1985-12-04
PACESETTER SYSTEMS
PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI1985-12-03
PACESETTER SYSTEMS
PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE1985-05-21
PACESETTER SYSTEMS
PROGRAMALITH III MODEL 249 PULSE GENERATOR1985-05-16
PACESETTER SYSTEMS
PROGRAMALITH III 240 PULSE GENERATOR1985-05-15
PACESETTER SYSTEMS
PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD1985-04-19
PACESETTER SYSTEMS
 ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP1985-04-12
PACESETTER SYSTEMS
PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD1985-04-10
PACESETTER SYSTEMS
PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR1985-04-01
PACESETTER SYSTEMS
PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR1985-03-06
PACESETTER SYSTEMS
PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD1985-02-14
PACESETTER SYSTEMS
MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 5041985-01-22
PACESETTER SYSTEMS
MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A1985-01-22
PACESETTER SYSTEMS
VIVALITH II 301 PULSE GENERATOR1985-01-10
PACESETTER SYSTEMS
PERMATHANE 865 & 867 UNIPOLAR POLYURETH1985-01-08
PACESETTER SYSTEMS
FASTPASS IMPLANTABLE ENDOCARDIAL PAC1984-08-03
PACESETTER SYSTEMS
MODEL 866 PERMATHANE BIPOLAR, COAXIAL1984-08-03
PACESETTER SYSTEMS
PACING ELECTRODE1984-03-12
PACESETTER SYSTEMS
 PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P1984-02-23
PACESETTER SYSTEMS
VASCUTEK VASCULAR PROTHESIS VP1200K/50K1983-12-21
PACESETTER SYSTEMS
PACEMAKER SYS ANALYZER #3841983-12-16
PACESETTER SYSTEMS
ENDOCARDIAL SCREW-IN LEAD 859 & 8611983-12-01
PACESETTER SYSTEMS
 PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P1983-11-21
PACESETTER SYSTEMS
PERMANTHANE #866 BIPOLAR COAXIAL1983-10-20
PACESETTER SYSTEMS
 ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP1983-09-20
PACESETTER SYSTEMS
INFUSION SETS #'S 124 & 142 PERSONAL1983-09-12
PACESETTER SYSTEMS
SINGLE USE SYRINGE #103 PERSONAL MEDIC1983-09-12
PACESETTER SYSTEMS
PACELINE PATIENT TRANSMITTER MODEL 3241983-08-12
PACESETTER SYSTEMS
 PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P1983-08-10
PACESETTER SYSTEMS
UNIPOLAR ATRIAL J PACING LEAD MODEL 8691983-06-08
PACESETTER SYSTEMS
VENTRICULAR PACING LEADS MODELS 865/8671983-06-08
PACESETTER SYSTEMS
 PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P1983-05-03
PACESETTER SYSTEMS
PERSONAL MEDICATION INFUSER1983-03-24
PACESETTER SYSTEMS
IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 2421983-03-24
PACESETTER SYSTEMS
AFP PULSE GENERATOR1983-02-18
PACESETTER SYSTEMS
AFP SYSTEM PULSE GENERATOR MODEL 261/2621983-02-18
PACESETTER SYSTEMS
 PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P1983-02-04
PACESETTER SYSTEMS
 ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP1983-01-27
PACESETTER SYSTEMS
PROGRAMALITH PROGRAMMER1983-01-08
PACESETTER SYSTEMS
ELECTRODE, PACEMAKER, PERMANENT1982-12-30
PACESETTER SYSTEMS
FASTPASS IMPLANTABLE ENDOCARD. PACING1982-08-06
PACESETTER SYSTEMS
PACEMAKER 445 ADAPTER1982-06-02
PACESETTER SYSTEMS
PACEMAKER CONNECTOR PLUG1982-06-02
PACESETTER SYSTEMS
PACEMAKER UNIPOLAR ADAPTER1982-06-02
PACESETTER SYSTEMS
PROGRAMMALITH II, #225 & 2261982-05-07
PACESETTER SYSTEMS
ADAPTING SLEEVE1981-12-02
PACESETTER SYSTEMS
TEST MAGNET1981-12-02
PACESETTER SYSTEMS
ELECTRODE TERMINAL CAP1981-12-02
PACESETTER SYSTEMS
VITATRON INSERT1981-12-02
PACESETTER SYSTEMS
DIRECTIONAL BOOT1981-12-02
PACESETTER SYSTEMS
PACEPATH IMPLANT. ENDOCARD. PACING LEAD1981-11-27
PACESETTER SYSTEMS
ELECTRODE, PACEMAKER, PERMANENT1981-11-27
PACESETTER SYSTEMS
PERSONAL MEDICATION INFUSER1981-11-06
PACESETTER SYSTEMS
MODEL 841 ENDOCARDIAL TINED LEAD1981-10-29
PACESETTER SYSTEMS
MODEL 833 ENDOCARDIAL TINED LEAD1981-10-29
PACESETTER SYSTEMS
PACEPATH IMPLANTABLE ENDOCARD. PACING LD1981-08-13
PACESETTER SYSTEMS
PACEMAKER LEAD ADAPTER1981-04-23
PACESETTER SYSTEMS
ELECTRODE, PACEMAKER PERMANENT1981-03-13
PACESETTER SYSTEMS
PACEMAKER LEAD ADAPTOR MODEL 4311980-10-31
PACESETTER SYSTEMS
PACEPATH MODEL 8101980-10-31
PACESETTER SYSTEMS
LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM1980-10-23
PACESETTER SYSTEMS
PACEPATH MODEL 8191980-10-23
PACESETTER SYSTEMS
PROGRAMALITH #'S 221, 222, 221A & 222A1980-09-26
PACESETTER SYSTEMS
VIVALITH 5, - MDL-201A & TDL-201A1980-08-27
PACESETTER SYSTEMS
MODEL 221 PROGRAMALITH PULSE GENERATOR1979-09-20
PACESETTER SYSTEMS
MODELS UL-804 AND BL-801 UNIPOLAR LEADS1979-09-04
PACESETTER SYSTEMS
MDL-201A & T DL-201A PULSE GENERATOR1979-08-10
PACESETTER SYSTEMS
BIPOLAR LEAD ADAPTOR, MODEL BA-4151979-08-10
PACESETTER SYSTEMS
PULSE GENERATOR, R WAVE DEMAND1979-08-10
PACESETTER SYSTEMS
PACING LEADS MODEL UL-811 AND UL-8131978-10-27
PACESETTER SYSTEMS
GENERATORS: UDL-201B, BDL-201B, MDL-201B1978-09-27
PACESETTER SYSTEMS
MDL-2011978-01-30
PACESETTER SYSTEMS
TDL-100 B1978-01-30
PACESETTER SYSTEMS
MODEL 100 CARDIAC PACEMAKER1976-11-11

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