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Medtronic Cardiac Rhythm Disease Management

2,694 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
VERSATRAX PACING SYSTEM (P820003/S123)Medtronic Cardiac Rhythm Disease Management2013-12-11
CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELLENCE PS+LEAD (P830061/S100)Medtronic Cardiac Rhythm Disease Management2013-11-26
CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATION IMPULSE II LEAD (P850089/S103)Medtronic Cardiac Rhythm Disease Management2013-11-26
ACH HEADER, END CAP, EPICARDIAL PATCH LEAD, SIZING SLEEVE, UPSIZING SLEEVE (P900061/S124)Medtronic Cardiac Rhythm Disease Management2013-11-26
LEAD ANCHORING SLEEVE KIT; SELECT SECURE LEAD (P030036/S066)Medtronic Cardiac Rhythm Disease Management2013-11-26
CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS (P010031/S402)Medtronic Cardiac Rhythm Disease Management2013-11-22
VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S441)Medtronic Cardiac Rhythm Disease Management2013-11-22
BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S406)Medtronic Cardiac Rhythm Disease Management2013-11-19
CAPSURE SENSE LEAD, CAPSURE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S099)Medtronic Cardiac Rhythm Disease Management2013-11-19
VARIOUS MODELS OF PASYS, SPECTRAX, SYMBIOS, SYNERGYST (P820003/S125)Medtronic Cardiac Rhythm Disease Management2013-11-19
EPICARDIAL PATCH LEAD (P900061/S123)Medtronic Cardiac Rhythm Disease Management2013-11-19
SELECTSECURE LEAD (P030036/S065)Medtronic Cardiac Rhythm Disease Management2013-11-19
EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRT (P980016/S445)Medtronic Cardiac Rhythm Disease Management2013-11-19
CAPSURE SP NOVUS LEAD,CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,VITATRON IMPULSE II LEAD (P850089/S102)Medtronic Cardiac Rhythm Disease Management2013-11-19
EVERA S DR ICD. EVERA S VR ICD, EVERA XT DR ICD; EVERA XT VR ICD, PROTECTA ICD, PROCTECTA XT ICD (P980016/S435)Medtronic Cardiac Rhythm Disease Management2013-10-31
BRAVA CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D VIVA S CRT-D, VIVA XT CRT-D (P010031/S396)Medtronic Cardiac Rhythm Disease Management2013-10-31
BRAVA CRT-D; VIVA S CRT-D; VIVA XT CRT-D (P010031/S398)Medtronic Cardiac Rhythm Disease Management2013-10-29
EVERA S DR ICD; EVERA S VR ICD; EVERA XT DR ICD; EVERA XT VR ICD (P980016/S437)Medtronic Cardiac Rhythm Disease Management2013-10-29
SELECTSECURE LEAD (P030036/S063)Medtronic Cardiac Rhythm Disease Management2013-10-25
BRAVA CRT-D,CONCERTO II CRT-D, CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S403)Medtronic Cardiac Rhythm Disease Management2013-10-23
EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECT XT ICD,SECURA ICD (P980016/S442)Medtronic Cardiac Rhythm Disease Management2013-10-23
CAPSURE SP Z LEAD (P850089/S101)Medtronic Cardiac Rhythm Disease Management2013-10-17
CAPSURE SENSE LEAD,CAPSURE SP NOVUS LEAD,VITATRON CRYSTALLINE LEAD,VITATRON EXCELLENCE PS+ LEAD (P830061/S098)Medtronic Cardiac Rhythm Disease Management2013-10-17
SELECTSECURE LEAD (P030036/S064)Medtronic Cardiac Rhythm Disease Management2013-10-17
CONSULTA CRT D, MAXIMO II CRT-D, CONCERTO II CRT -D, CONCERTO CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA XT CRT-D, V (P010031/S394)Medtronic Cardiac Rhythm Disease Management2013-10-15
ENTRUST, VIRTUOSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, INSYNC MARQUIS, PROTECTA XT, DR, PROTEXTA DR, PROTEXTA XT, VR, (P980016/S433)Medtronic Cardiac Rhythm Disease Management2013-10-15
EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD (P980016/S440)Medtronic Cardiac Rhythm Disease Management2013-10-10
SELECTSECURE LEAD (P030036/S062)Medtronic Cardiac Rhythm Disease Management2013-10-10
CAPSURE SP NOVUS LEAD,CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,VITATRON IMPULSE II LEAD (P850089/S100)Medtronic Cardiac Rhythm Disease Management2013-10-10
BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S400)Medtronic Cardiac Rhythm Disease Management2013-10-10
EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD (P980016/S439)Medtronic Cardiac Rhythm Disease Management2013-10-10
CAPSURE SENSE LEAD,CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD,VITATRON EXCELLENCE PS+ LEAD (P830061/S097)Medtronic Cardiac Rhythm Disease Management2013-10-10
BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S401)Medtronic Cardiac Rhythm Disease Management2013-10-10
SELECTSECURE LEAD (P030036/S061)Medtronic Cardiac Rhythm Disease Management2013-10-10
VIRTUOSO DR,VIRTUOSO VR,SECURA DR,MAXIMO II DR,VIRTUOSO II DR,SECURA VR,MAXIMO II VR,VIRTUOSO II VR,PROTECTA XT DR,PROTE (P980016/S431)Medtronic Cardiac Rhythm Disease Management2013-10-07
CONSULTA CRT D,MAXIMO II CRT-D,CONCERTO II CRT-D,CONCERTO CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA XT CRT-D,VIVA S,BR (P010031/S392)Medtronic Cardiac Rhythm Disease Management2013-10-07
BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S387)Medtronic Cardiac Rhythm Disease Management2013-10-04
EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S426)Medtronic Cardiac Rhythm Disease Management2013-10-04
BRAVA CRT-D, VIVA S CRT-D AND VIVA XT CRT-D (P010031/S399)Medtronic Cardiac Rhythm Disease Management2013-10-02
EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S438)Medtronic Cardiac Rhythm Disease Management2013-10-02
INSYNC II PROTECT, INSYNC III MARQUIS,INSYNC MARQUIS, INSYNC MAXIMO ICDS (P010031/S386)Medtronic Cardiac Rhythm Disease Management2013-09-27
ENTRUST,INTRINSIC 30,INTRINSIC,MARQUIS DR,MARQUIS VR,MAXIMO DR,MAXIMO VR ICDS (P980016/S425)Medtronic Cardiac Rhythm Disease Management2013-09-27
PROTECTA XT CRT-D, PROTECTA CRT-D, CONSULTA CRT-D, CONCERTO II CRT-D, MAXIMO II CRT-D (P010031/S344)Medtronic Cardiac Rhythm Disease Management2013-09-25
PROTECTA XT ICD, PROTECTA ICD, SECURA ICD, VIRTUOSO II ICD, MAXIMO II ICD (P980016/S394)Medtronic Cardiac Rhythm Disease Management2013-09-25
EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S432)Medtronic Cardiac Rhythm Disease Management2013-09-03
BRAVA CRT-D, VIVA S CRT-D AND VIVA XT CRT-D (P010031/S393)Medtronic Cardiac Rhythm Disease Management2013-09-03
BRAVA CRT-D, CONCERTO II CRT-D, COSULTA ICD, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D, PROTECTA CRT-D (P010031/S391)Medtronic Cardiac Rhythm Disease Management2013-08-22
EVERA S DR ICD, S VR ICD, XT DR ICD, XT VR ICD; INTRINSIC ICD; MARQUIS DR ICD, VR ICD; MAXIMO DR ICD, MAXIMO II ICD, MAX (P980016/S430)Medtronic Cardiac Rhythm Disease Management2013-08-22
BRAVA,VIVA S,VIVA XT CRT-DS (P010031/S390)Medtronic Cardiac Rhythm Disease Management2013-08-22
EVERA S DR,EVERA S VR,EVERA XT DR,EVERA XT VR ICDS (P980016/S429)Medtronic Cardiac Rhythm Disease Management2013-08-22
EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S427)Medtronic Cardiac Rhythm Disease Management2013-08-14
BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S388)Medtronic Cardiac Rhythm Disease Management2013-08-14
CONSULTA ICD & BRAVA, CONCERTO II, MAXIMO II,PROTECTA/PROTECTA XT, VIVA S/XT CRT- D'S (P010031/S389)Medtronic Cardiac Rhythm Disease Management2013-08-12
EVERA S DR/VR & XT DR/ VR, MAXIMO II, PROTECTA/PROTECTA XT, SECURA, VIRTUOSO II DR/ VR ICD'S (P980016/S428)Medtronic Cardiac Rhythm Disease Management2013-08-12
MODEL 5348 SINGLE CHAMBER TEMPORARY PACEMAKER (AAI/VVI) AND MODEL 5388 DUAL CHAMBER TEMPORARY PACEMAKER (P820003/S122)Medtronic Cardiac Rhythm Disease Management2013-08-09
EVERA S DR ICD, EVERA S VR ICD EVERA XT DR ICD, EVERA XT VR ICD (P980016/S424)Medtronic Cardiac Rhythm Disease Management2013-07-26
MAXIMO II ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S423)Medtronic Cardiac Rhythm Disease Management2013-07-26
BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S385)Medtronic Cardiac Rhythm Disease Management2013-07-26
CONCERTO II CRT-D, CONSULTA ICD, MAXIMO CRT-D (P010031/S384)Medtronic Cardiac Rhythm Disease Management2013-07-26
SELECTSECURE LEAD (P030036/S058)Medtronic Cardiac Rhythm Disease Management2013-07-23
BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICDM INSYNC III MARQUIS (P010031/S377)Medtronic Cardiac Rhythm Disease Management2013-07-23
ACE HEADER, END CAP, SIZING SLEEVE, , UPSIZING SLEEVE (P900061/S122)Medtronic Cardiac Rhythm Disease Management2013-07-23
EVERA S DR ICD, S VR ICD,XT DR ICD, XT VR ICD, INTRINISIC ICD, MARQUIS DR ICD, VR ICD, MAXIMO DR ICD, MAXIMO II ICD; VR (P980016/S417)Medtronic Cardiac Rhythm Disease Management2013-07-23
CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD (P850089/S098)Medtronic Cardiac Rhythm Disease Management2013-07-23
ADHESIVE, CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELENCE PS+LEAD (P830061/S093)Medtronic Cardiac Rhythm Disease Management2013-07-23
CONSULTA CRT D,MAXIMO II CRT-D,CONCERTO II CRT-D,CONCERTO CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA XT CRT-D,VIVA S (P010031/S376)Medtronic Cardiac Rhythm Disease Management2013-07-15
VIRTUOSO DR,VIRTUOSO VR,SECURA DR, MAXIMO II DR,VIRTUOSO II DR,SECURA VR,MAXIMO II VR,VIRTUOSO II VR,PROTECTA XT DR (P980016/S416)Medtronic Cardiac Rhythm Disease Management2013-07-15
EVERA S DR ICD, EVER S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA IC (P980016/S422)Medtronic Cardiac Rhythm Disease Management2013-07-03
BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S383)Medtronic Cardiac Rhythm Disease Management2013-07-03
CAPSURE SENSE BIPOLAR LEADS (P830061/S096)Medtronic Cardiac Rhythm Disease Management2013-07-03
CONCERTO ICD,CONCERTO II CRT-D,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROT (P010031/S380)Medtronic Cardiac Rhythm Disease Management2013-06-26
INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO II ICD,MAXIMO VR ICD,PROTECTA ICD,PROTECTA XT ICD,SECUR (P980016/S420)Medtronic Cardiac Rhythm Disease Management2013-06-26
EVERA S DR ICD , D VR ICD, ST DR ICD, XT VR ICD; MAXIMO II ICD, PROTECTA ICD/ XT ICD; SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S421)Medtronic Cardiac Rhythm Disease Management2013-06-24
BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D/ XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S382)Medtronic Cardiac Rhythm Disease Management2013-06-24
CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD (P850089/S099)Medtronic Cardiac Rhythm Disease Management2013-06-19
EVERA S DR ICD,EVERA S VR, ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S419)Medtronic Cardiac Rhythm Disease Management2013-06-19
BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S379)Medtronic Cardiac Rhythm Disease Management2013-06-19
LEAD ANCHORING SLEEVE KIT (P030036/S059)Medtronic Cardiac Rhythm Disease Management2013-06-19
CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCLLENCE PS+ LEAD (P830061/S094)Medtronic Cardiac Rhythm Disease Management2013-06-19
BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, VIVA S CRT-D (P010031/S378)Medtronic Cardiac Rhythm Disease Management2013-06-14
EVERA S DR ICD, EVERA S VR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S418)Medtronic Cardiac Rhythm Disease Management2013-06-14
GEM,JEWEL,MOCRO JEWEL,JEWEL PLUS,MICRO JEWEL II,PCD (P900061/S121)Medtronic Cardiac Rhythm Disease Management2013-06-11
PASYS,PASYS ST,SPECTRAX S,SPECTAX SX,SPECTRAX SX-HT,SPECTRAX SXT,SYMBIOS,SYMBIOS(AA),SYNERGYST (P820003/S120)Medtronic Cardiac Rhythm Disease Management2013-06-11
CONCERTO, RIGHT VENTRICULAR LEAD INTEGRITY ALERT, CONCERTO-II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC II MARQUIS, INSY (P010031/S373)Medtronic Cardiac Rhythm Disease Management2013-06-11
ENTRUST,GEM,GEM II,GEM III,INTRINSIC,MARQUIS,MAXIMO,MAXIMO II,ONYX,PROTECTA DF4,PROTECTA,PROTECTA XT DF4,PROTECTA XT (P980016/S413)Medtronic Cardiac Rhythm Disease Management2013-06-11
5846 DISPOSABLE PATIENT CABLE (P820003/S121)Medtronic Cardiac Rhythm Disease Management2013-06-06
VERSATRAX PACING SYSTEM (P820003/S117)Medtronic Cardiac Rhythm Disease Management2013-05-30
SELECTSECURE LEAD (P030036/S057)Medtronic Cardiac Rhythm Disease Management2013-05-29
CAPSURE SP NOVUS LEAD,CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,IMPULSE II LEAD (P850089/S097)Medtronic Cardiac Rhythm Disease Management2013-05-29
CAPSURE LEAD,VITATRON CRYSTALINE LEAD,VITATRON EXCELLENCE PS+LEAD (P830061/S092)Medtronic Cardiac Rhythm Disease Management2013-05-29
INSYNC II P ROTECT ICD, INSYNC III MARQUIS ICD, INSYNC MARQUIS ICD, INSYNC MAXIMO ICD (P010031/S363)Medtronic Cardiac Rhythm Disease Management2013-05-24
ENTRUST ICD, INTRINSIC 30 ICD, INTRINSIC ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO VR IC (P980016/S400)Medtronic Cardiac Rhythm Disease Management2013-05-24
CAPSURE SENSE BIPOLAR LEAD (P830061/S091)Medtronic Cardiac Rhythm Disease Management2013-05-23
EVERA S DR,EVERA S VR,EVERA XT DR,EVERA XT VR,MAXIMO II,PROTECTA,PROTECTA XT,SECURA,VIRTUOSO II DR/VR ICDS (P980016/S415)Medtronic Cardiac Rhythm Disease Management2013-05-22
BRAVA,CONCERTO II,MAXIMO II,PROTECTA,PROTECTA XT,VIVA S,VIVA XT CRTS,CONSULTA ICD (P010031/S375)Medtronic Cardiac Rhythm Disease Management2013-05-22
EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRT (P980016/S414)Medtronic Cardiac Rhythm Disease Management2013-05-14
BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S374)Medtronic Cardiac Rhythm Disease Management2013-05-14
BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S371)Medtronic Cardiac Rhythm Disease Management2013-05-07
EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR (P980016/S410)Medtronic Cardiac Rhythm Disease Management2013-05-07
EVERA S DR, EVERA S VR, EVERA XT DR (P980016/S408)Medtronic Cardiac Rhythm Disease Management2013-05-03
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Every clearance here is in the API, with alerts when new ones post.