Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Pacesetter Systems

FDA 510(k) & PMA Approved Devices — 96 products

Total Devices96
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K910924 ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONEDTB1991-08-28 View
510(k) K902147 ENDOCARDIAL SCREW-IN LEAD MODEL 1028TDTB1990-07-17 View
510(k) K900512 SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERSDTD1990-06-25 View
510(k) K900550 FAST-PASS ACE MODELS 1212T/1222T/1216T/1226TDTB1990-04-20 View
510(k) K895447 ENDOCARDIAL SCREW-IN LEAD MODEL 1020TDTB1989-12-20 View
510(k) K891905 CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODEDTB1989-06-05 View
510(k) K885267 VS-1 MODEL NUMBER 251K PULSE GENERATORDXY1989-03-28 View
510(k) K890547 SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERSDTB1989-03-22 View
510(k) K884733 AFP MODEL 262T PULSE GENERATORDXY1989-02-10 View
510(k) K883087 PROLOG MP 658M PULSE GENERATORDXY1988-09-14 View
510(k) K874205 ENDOCARDIAL SCREW-IN LEAD, MODEL 1018TDTB1988-02-02 View
510(k) K872779 PROLOG MP PULSE GENERATORS 658K AND 658TDXY1987-11-04 View
510(k) K873931 MODIFIED MODELS 1025M & 1026T PACING LEADDTB1987-10-22 View
510(k) K871208 UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007MDYB1987-06-05 View
510(k) K870824 ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035DTB1987-03-20 View
510(k) K862226 DIALOG MODELS 748, 748K AND 748T PULSE GENERATORSDXY1987-02-03 View
510(k) K861422 PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITYDXY1986-06-26 View
510(k) K861436 SOF SET, MODELS 111 AND 112FRN1986-06-09 View
510(k) K861481 ENDOCARDIAL CARBON-TIP LEADDTB1986-06-06 View
510(k) K860857 SOF SET, MODELS 113 AND 114FRN1986-05-27 View
↑