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Medtronic Cardiac Rhythm Disease Management

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

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RecordFirmDate
Amplia, Brava, Claria , Compia, Converto, Maximo, Protecta, Viva (P010031/S572)Medtronic Cardiac Rhythm Disease Management2017-06-09
Evera MRI, Evera XT DR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Virtuoso II (P980016/S612)Medtronic Cardiac Rhythm Disease Management2017-06-09
Evera, Maximo, Protecta, Secura, Solara Quadripolar,Syncra, Viva MRI DF XT ICD CRT-P (P980016/S632)Medtronic Cardiac Rhythm Disease Management2017-06-08
Amplia, Brava, Claria, Compia, Consulta, Maximo, Protecta XT MRI/CRT-D, Viva Quad S AF VR ICD (P010031/S593)Medtronic Cardiac Rhythm Disease Management2017-06-08
Evera MRI DF-1 ICD DVMB1D1, DDMB1D1, DDMC3D1, DVMC3D1; Evera MRI ICD DDMC3D4, DVMB1D4, DVMC3D4, DDMB1D4; Evera S DR ICD (P980016/S633)Medtronic Cardiac Rhythm Disease Management2017-06-08
Amplia MRI CRTD DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4; DTBC1D1; Brava Quad CRTD (P010031/S594)Medtronic Cardiac Rhythm Disease Management2017-06-08
Amplia, Brava, Claria, Compia, Consulta, Maximo, Protecta, Viva Quad MRI CRT-D (P010031/S592)Medtronic Cardiac Rhythm Disease Management2017-05-15
Evera, Maximo, Protecta, Secura, Visia MRI VR/XT/DR/AF ICD (P980016/S631)Medtronic Cardiac Rhythm Disease Management2017-05-15
SELECTSECURE LEAD MODEL 3830 (P030036/S091)Medtronic Cardiac Rhythm Disease Management2017-05-06
CAPSURE SENSE MRI SURESCAN LEAD (P830061/S141)Medtronic Cardiac Rhythm Disease Management2017-05-06
SELECTSECURE MRI SURESCAN LEAD (P030036/S092)Medtronic Cardiac Rhythm Disease Management2017-05-06
CAPSURE SENSE MRI SURESCAN LEAD (P830061/S140)Medtronic Cardiac Rhythm Disease Management2017-05-06
Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Max (P980016/S629)Medtronic Cardiac Rhythm Disease Management2017-04-28
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT_D, Compia (P010031/S589)Medtronic Cardiac Rhythm Disease Management2017-04-28
Evera, Visia MRI ICD, S VR ICD, XT VR ICD (P980016/S628)Medtronic Cardiac Rhythm Disease Management2017-04-26
Amplia, Amplia MRI Quad, Brava, Brava MRI Quad, Claria MRI, Compia, Viva XT CRT-D (P010031/S588)Medtronic Cardiac Rhythm Disease Management2017-04-26
AMPLIA MRI AND AMPLIA MRI QUAD CRT-D SURESCAN MODELS DTMB1D4, DTMB1QQ. COMPIA MRI, CLARIA MRI (P010031/S577)Medtronic Cardiac Rhythm Disease Management2017-04-25
EVERA MRI XT DR SURESCAN MODELS DDMB1D4, EVERA MRI ST VR SURESCAN MODEL DVMB1D4, VISIA AF MRI VR SURESCAN DVFC3D4 IMPLAN (P980016/S618)Medtronic Cardiac Rhythm Disease Management2017-04-25
SELECTSECURE MRI SURESCAN LEAD MODEL 3830 (P030036/S093)Medtronic Cardiac Rhythm Disease Management2017-04-25
MEDTRONIC SELECTSECURE LEAD MODEL 3830 (P030036/S088)Medtronic Cardiac Rhythm Disease Management2017-04-25
Amplia MRI and Amplia MRI Quad CRT-D SureScan , Compia MRI and Compia MRI Quad CRT-D SureScan, Claria MRI and Claria MRI (P010031/S569)Medtronic Cardiac Rhythm Disease Management2017-04-25
CAPSURE SENSE MRI SURESCAN LEAD MODEL 4574 (P830061/S143)Medtronic Cardiac Rhythm Disease Management2017-04-25
CapSure Sense MRI SureScan Leads (P830061/S137)Medtronic Cardiac Rhythm Disease Management2017-04-25
Evera MRI XT DR /VR SureScan; Evera MRI S DR/VR SureScan; Visia AF MRI XT Surescan; Visia AF MRI S VR Surescan DVFC3D4 A (P980016/S609)Medtronic Cardiac Rhythm Disease Management2017-04-25
Evera MRI DF-1/Evera MRI/Evera S DR/Evera S VR/Evera XT DR/Evera XT VR/Maximo II/Protecta/Protecta VR/Protecta XT/Secura (P980016/S630)Medtronic Cardiac Rhythm Disease Management2017-04-23
Amplia MRI/Amplia MRI Quad/Brava/Brava Quad/Claria MRI/Claria MRI Quad/Compia MRI/Compai MRI Quad/Consulta/Maximo II/Pro (P010031/S590)Medtronic Cardiac Rhythm Disease Management2017-04-23
Amplia MRI CRT-D/Amplia MRI Quad CRT-D/ Brava CRT-D/ Brava Quad CRT-D/ Claria MRI CRT-D/ Claria MRI Quad CRT-D/ Compia M (P010031/S583)Medtronic Cardiac Rhythm Disease Management2017-04-14
Evera MRI DF-I ICD/Evera MRI ICD/ Evera S DR ICD/Evera S VR ICD/ Evera XT DR ICD/ Evera XT VR ICD/ Visia AF MRI DF1 ICD/ (P980016/S624)Medtronic Cardiac Rhythm Disease Management2017-04-14
Medtronic Cardiac Rhythm and Heart Failure (P010031/S587)Medtronic Cardiac Rhythm Disease Management2017-04-12
Amplia MRI CRT-D, Claria MRI CRT-D, Compia MRI CRT-D (P010031/S584)Medtronic Cardiac Rhythm Disease Management2017-04-12
VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S627)Medtronic Cardiac Rhythm Disease Management2017-04-12
Amplia MRI CRT-D,MRI Quad CRT-D; Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D; Concerto II CRT (P010031/S586)Medtronic Cardiac Rhythm Disease Management2017-03-30
Evera MRI ICD, Evera S DR/ S VR ICD's; Evera XT DR ICD/ XT VR ICD; Maximo II ICD; Protecta VR/XT ICD; Secura DR ICD, Sec (P980016/S626)Medtronic Cardiac Rhythm Disease Management2017-03-30
Claria MRI Quad CRT-D SureScan, Amplia MRI Quad CRT-D, Implantable Cardioverter Defibrillators with Cardiac Resynchroniz (P010031/S563)Medtronic Cardiac Rhythm Disease Management2017-03-24
Amplia MRI, Amplia MRI Quad, Brava, Brava Quad, Claria MRI, Claria Quad, Compia MRI, Compia MRI Quad, Viva Quad S, Viva (P010031/S585)Medtronic Cardiac Rhythm Disease Management2017-03-13
Evera MRI DF-1, Evera MRI, Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Visia AF MRI DF1, Visia AF MRI VR, Visia AF (P980016/S625)Medtronic Cardiac Rhythm Disease Management2017-03-13
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Evera MRI ICD, Maximo II ICD (P010031/S582)Medtronic Cardiac Rhythm Disease Management2017-03-10
Evera MRI DF-1, Protecta XT ICD (P980016/S623)Medtronic Cardiac Rhythm Disease Management2017-03-10
Evera MRI DF-1 ICD/ Evera MRI ICD/Evera S DR ICD/ Evera S VR ICD/ Evera XT DR ICD/Evera XT VR ICD/ Visia AF MRI DF1 ICD/ (P980016/S622)Medtronic Cardiac Rhythm Disease Management2017-03-08
Amplia MRI CRT-D/Amplia MRI Quad CRT-D/ Brava CRT-D/Claria Quad CRT-D/ Brava Quad CRT-D/ Compia MRI Quad CRT-D/ Viva Qua (P010031/S581)Medtronic Cardiac Rhythm Disease Management2017-03-08
Amplia MRI/Amplia MRI Quad/Brava/Brava Quad/Claria MRI/Claria MRI Quad/Compia MRI/Concerto II/Consulta/Maximo II/Viva Qu (P010031/S580)Medtronic Cardiac Rhythm Disease Management2017-02-28
Evera MRI DF-1/Evera MRI/Evera S DR/Evera S VR/Evera XT DR/Evera XT VR/Maximo II/Secura DR/Serura/Virtuoso II DR/VR/Visi (P980016/S621)Medtronic Cardiac Rhythm Disease Management2017-02-28
Evera MRI DF-1ICD DDMB1D1, DDMC3D1 L; Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; (P980016/S619)Medtronic Cardiac Rhythm Disease Management2017-02-21
Amplia MRI CRTD DTMB1D4, DTMB1D1; Amplia MRI Quad CRT-D DTMB1QQ, DTMB1Q1; Brava CRT-D DTBC1D4, DTBC1D1, Brava Quad CRTD (P010031/S578)Medtronic Cardiac Rhythm Disease Management2017-02-21
Viva, Brava, Protecta, Protecta XT, Concerto, Concerto II, Consulta, Maximo II, (P010031/S573)Medtronic Cardiac Rhythm Disease Management2017-02-17
Evera MRI, Evera, Marquis, Secura, Maximo II, Intrinsic, Protecta, Protecta XT, (P980016/S613)Medtronic Cardiac Rhythm Disease Management2017-02-17
CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS (P850089/S123)Medtronic Cardiac Rhythm Disease Management2017-02-14
EPICARDIAL PATCH LEAD (P900061/S145)Medtronic Cardiac Rhythm Disease Management2017-02-14
CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S142)Medtronic Cardiac Rhythm Disease Management2017-02-14
Visia AF software SW035 Version 8.1 (P980016/S615)Medtronic Cardiac Rhythm Disease Management2017-02-14
VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S617)Medtronic Cardiac Rhythm Disease Management2017-02-07
CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S576)Medtronic Cardiac Rhythm Disease Management2017-02-07
AMPLIA MRI CRT-D, AMPLIA MRI QUAD CRT-D, BRAVA CRT-D, BRAVA QUAD CRT-D, CLARIA MRI CRT-D, CLARIA MRI QUAD CRT-D, COMPIA (P010031/S570)Medtronic Cardiac Rhythm Disease Management2017-02-02
EVERA MRI DF-1 ICD, EVERA MRI IDC, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, VISIA AF MRI DF1 IC (P980016/S610)Medtronic Cardiac Rhythm Disease Management2017-02-02
Evera MRI, S DR, S VR, XT DR, XTVR ICD's; Maximo II ICD; Protecta VR, XT ICDs; Secura DR ICD's; Virtuose II DR/VR ICD; V (P980016/S606)Medtronic Cardiac Rhythm Disease Management2017-01-06
Amplia MRI/MRI Quad CRT-D's; Brava CRT-D; Compia MRI/MRI Quad CRT-Ds; Concerto II CRT-D; Consulta CRT-D; Maximo II CRT-D (P010031/S567)Medtronic Cardiac Rhythm Disease Management2017-01-06
AMPLIA MRI CRT-D & QUAD CRT-D; BRAVA CRT-D & QUAD CRT-D; CLARIA MRI CRT-D & QUAD CRT-D; COMPIA MRI CRT-D & QUAD CRT-D ; (P010031/S574)Medtronic Cardiac Rhythm Disease Management2016-12-19
CAPSURE SENSE LEAD /SP LEAD / CAPSURE SP NOVUS LEAD/ VITATRON CRYSTALLINE LEAD/ VITATRON EXCELLENCE PS + LEAD (P830061/S139)Medtronic Cardiac Rhythm Disease Management2016-12-19
EVERA MRI ICD/ S DR/ S VR/ XT DR / XTVR ICD; MAXIMO II ICD ; VIVA QUAD XT CRT-D; VIVA S CRT-D; VIVA XT CRT-D (P980016/S614)Medtronic Cardiac Rhythm Disease Management2016-12-19
SELECTSECURE LEAD (P030036/S090)Medtronic Cardiac Rhythm Disease Management2016-12-19
CAPSURE SP NOVUS LEAD / Z LEAD ; CAPSURE Z NOVUS LEAD ; VITATRON IMPLUSE II LEAD (P850089/S122)Medtronic Cardiac Rhythm Disease Management2016-12-19
CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S571)Medtronic Cardiac Rhythm Disease Management2016-12-14
VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S611)Medtronic Cardiac Rhythm Disease Management2016-12-14
MEDTRONIC SELECTSECURE LEAD/ANCHORING SLEEVE KIT (P030036/S089)Medtronic Cardiac Rhythm Disease Management2016-12-14
ADHESIVE, CAPSURE SENSE LEAD, CAPSURE SP LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE AND EXCELLENCE PS+ LEAD (P830061/S138)Medtronic Cardiac Rhythm Disease Management2016-12-14
MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM (P900061/S144)Medtronic Cardiac Rhythm Disease Management2016-12-14
DISPOSABLE EPG COVER/DISPOSABLE POUCH (P820003/S137)Medtronic Cardiac Rhythm Disease Management2016-12-14
CAPSURE SP NOVUS, CAPSURE SP Z, CAPSURE Z NOVUS, VITATRON IMPULSE II LEAD (P850089/S121)Medtronic Cardiac Rhythm Disease Management2016-12-14
Claria MRI CRT-D QUAD SureScan; Amplia MRI Quad CRT-D SureScan; Compia MRI CRT-D SureScan (P010031/S568)Medtronic Cardiac Rhythm Disease Management2016-11-23
Evera MRI XT DR, VR, S DR, S VR SureScan ICD; Visia AF MRI XT, S VR SureScan ICD (P980016/S608)Medtronic Cardiac Rhythm Disease Management2016-11-23
Evera MRI; S DR,VR;XT DR,VR, ICD; Intrinsic 30 ICD; Marquis VR ICD; Maximo II ICD; Protecta XT ICD; Secura ICD; Virtuoso (P980016/S600)Medtronic Cardiac Rhythm Disease Management2016-11-17
Brava CRT-D; Brava Quad CRT-D; Concerto ICD,II CRT-D; Consulta CRT-D; InSync II Protect ICD; Maximo II CRT-D; Protecta X (P010031/S560)Medtronic Cardiac Rhythm Disease Management2016-11-17
Evera MRI XT DR SureScan ICD DDMB1D1, Evera MRI XT VR SureScan ICD DVMB1D1, Evera MRI S DR SureScan ICD DDMC3D1, Evera M (P980016/S607)Medtronic Cardiac Rhythm Disease Management2016-11-14
ADHESIVE/CAPSURE SENSE/CAPSURE SP NOVUS/VITATRON CRYSTALLINE/VITATRON EXCELLENCE PS+ LEADS (P830061/S136)Medtronic Cardiac Rhythm Disease Management2016-11-02
Evera S DR,VR ICD; Evera XT DR, VR ICD (P980016/S605)Medtronic Cardiac Rhythm Disease Management2016-11-02
END CAP/UPSIZING SLEEVE (P900061/S143)Medtronic Cardiac Rhythm Disease Management2016-11-02
ANCHORING SLEEVE KIT/SELECTSECURE LEAD (P030036/S087)Medtronic Cardiac Rhythm Disease Management2016-11-02
CAPSURE SP NOVUS/CAPSURE SP Z/CAPSURE Z NOVUS/VITATRON IMPULSE II LEADS (P850089/S120)Medtronic Cardiac Rhythm Disease Management2016-11-02
Brava,Brava Quad CRT-D; Viva S, XT,Viva Quad S, XT CRT-D (P010031/S566)Medtronic Cardiac Rhythm Disease Management2016-11-02
CAPSURE SENSE MRI SURESCAN LEAD MODEL 4574 (P830061/S130)Medtronic Cardiac Rhythm Disease Management2016-10-25
CLARIA MRI CRT-D SURESCAN MODEL DTMA1D4; QUAD MODEL DTMA1QQ; MODEL DTMA1D1, MODEL DTMBIQ1, MODEL DTMB1Q1,MODEL DTMC1D1, (P010031/S550)Medtronic Cardiac Rhythm Disease Management2016-10-25
Amplia MRI CRT-D & QUAD CRT-D, Brava CRT-D, Brava Quad CRT-D, Compia MRI CRT-D & MRI Quad CRT-D, Viva Quad S & XT CRT-D' (P010031/S564)Medtronic Cardiac Rhythm Disease Management2016-10-24
Evera MRI, S DR, S VR, XT DR, XT VR ICD's; Visia AF MRI VR ICD & Visia AF VR ICD (P980016/S603)Medtronic Cardiac Rhythm Disease Management2016-10-24
Amplia MRI CRT-D & Quad CRT-D, Brava CRT-D & Quad CRT-D, Compia MRI CRT-D & Quad CRT-D, Concerto II CRT-D, Consulta CRT- (P010031/S562)Medtronic Cardiac Rhythm Disease Management2016-10-24
Evera MRI, S DR, S VR, XT DR, XT VR ICD'S; Maximo Ii ICD; Protecta ICD, XT ICD; Secura DR ICD, Secura ICD; Virtuoso II D (P980016/S602)Medtronic Cardiac Rhythm Disease Management2016-10-24
MAXIMO II/PROTECTA/PROTECTA VR/PROTECTA XT/SECURA DR/SECURA/VIRTUOSO II DR/VR ICDs (P980016/S604)Medtronic Cardiac Rhythm Disease Management2016-10-18
CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT CRT-Ds (P010031/S565)Medtronic Cardiac Rhythm Disease Management2016-10-18
MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM (P900061/S142)Medtronic Cardiac Rhythm Disease Management2016-10-17
CAPSURE SENSE MRI SURESCAN LEAD MODELS 4074 AND 4574. (P830061/S129)Medtronic Cardiac Rhythm Disease Management2016-10-12
EVERA MRI XT DR SURESCAN MODEL DDMB1D1, EVERA MRI XT VR SURESCAN MODEL DVMB1D1, EVERA MRI S DR SURESCAN MODEL DDMC3D1, E (P980016/S586)Medtronic Cardiac Rhythm Disease Management2016-10-12
CapSure Sense, SP Novus Lead: Vitatron Crystalline, Excellence PS+ Lead; (P830061/S135)Medtronic Cardiac Rhythm Disease Management2016-10-06
Amplia, Brava, Compia, Concerto II. Consulta, Maximo II, Protecta, Protecta XT, Viva S,XT, Quad CRT-D (P010031/S561)Medtronic Cardiac Rhythm Disease Management2016-10-04
Evera S, Maximo II, Protecta, Secura,Quad XT CRT-D; Virtuoso II, Visia AF, MRI VR ICD, (P980016/S601)Medtronic Cardiac Rhythm Disease Management2016-10-04
Patient Cable (P820003/S136)Medtronic Cardiac Rhythm Disease Management2016-09-29
Patient Magnet (P900061/S141)Medtronic Cardiac Rhythm Disease Management2016-09-29
Patient Magnet (P980016/S599)Medtronic Cardiac Rhythm Disease Management2016-09-29
CAPSURE SENSE LEAD; CAPSURE SP NOVUS LEAD; VITATRON CYRSTALLINE LEAD; VITATRON EXCELLENCE PS+ LEAD (P830061/S134)Medtronic Cardiac Rhythm Disease Management2016-09-28
CAPSURE SP NOVUS/CAPSURE SP Z/CAPSURE Z NOVUS LEADS, VITATRON IMPULSE II LEAD (P850089/S119)Medtronic Cardiac Rhythm Disease Management2016-09-28
CapSure Sense Lead Models 4074, 4574 (P830061/S133)Medtronic Cardiac Rhythm Disease Management2016-09-21
CapSure Sense Lead; Vitatron Crystalline Lead, ICM09 (P830061/S132)Medtronic Cardiac Rhythm Disease Management2016-09-20
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