FDA.report

Product code NIK

Current FDA Classification

Device name
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Medical specialty
Unknown
Device class
3
Review panel
CV
Implant
Y
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.

Related PMA Records

PMADeviceApplicantDecision date
P010012S511CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLLBoston Scientific Corp.2019-11-15
P010031S682Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, CompiaMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-11-01
P010012S510Cardiac Resynchronization Therapy Defibrillator (CRT-D)Boston Scientific Corp.2019-10-29
P010012S508CRT-D Resynchronization s: COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUMBoston Scientific Corp.2019-10-18
P030054S371Quadra Assura, Unify, Unify Assura and Unify Quadra CRT-DSt. Jude Medical2019-10-15
P010031S680Amplia 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 MMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-10-04
P010031S681Amplia, Claria MRI CRT-D, Amplia, Claria and Compia MRI Quad CRT-D, Brava Quad CRT-D, Brava, Consulta and Protecta CRT-DMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-09-27
P010012S509Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, and Resonate Cardiac Resynchronization Therapy Defibrillator (CRT-Boston Scientific Corp.2019-09-24
P010031S679Amplia MRI, MRI Quad, Brava, Brava Quad, Claria MRI, MRI Quad, Compia MRI, MRI Quad, and Viva Quad S, Quad XT, S, XT CRTMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-09-13
P030054S370Quadra Assura, Unify, Unify Assura, and Unify Quadra CRT-D sSt. Jude Medical2019-09-04
P010031S678Consulta, Protecta and Protecta XT CRT-DMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-08-30
P030054S369Unify, Unify Quadra/Assura and Quadra Assura/MPSt. Jude Medical2019-08-19
P010031S677Amplia MRI/Quad, Brava/Quad, Claria MRI/Quad, Compia MRI/Quad, Consulta, Protecta/XT, Viava Quad S/XT, Viva S/XT CRT-DMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-08-06
P010031S675CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATIONMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-07-26
P010031S676Amplia, Amplia Quad; Brava, Brava Quad; Claria, Claria Quad; Compia, Compia Quad; Consulta; Protecta, Protecta XT; VivaMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-07-22
P010012S507Momentum, Resonate, Autogen, and Dynagen (CRT-D)Boston Scientific Corp.2019-07-18
P010031S673Amplia MRI and MRI Quad CRT-D, Brava CRT-D and Quad CRT-D, Claria MRI and MRI Quad CRT-D, Compia MRI and MRI Quad CRT-D,MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-07-18
P010031S671Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, CompiaMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-07-11
P010031S670Amplia MRI CRT-D, Amplia MRI Quard CRt-P, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, CompiaMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-06-26
P010031S669CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATIONMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-06-21
P010012S505NG3 and NG4 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)Boston Scientific Corp.2019-06-21
P010012S501CRT-D Resynchronization s COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM,Boston Scientific Corp.2019-06-10
P010031S668Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brav CRT-D, Brava Quad CRT-D, Claria MRi CRT-D, Claria MRI Quad CRT-D, Compia MMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-06-05
P010031S667Amplia MRI CRT-D SureScan, Amplia MRI Quad CRT-D SureScan, Compia MRI CRT-D SureScan, Compia MRI Quad CRT-D SureScan andMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-05-30
P010031S666Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, CompiaMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-05-20
P010012S503Acuity X4 LinersBoston Scientific Corp.2019-05-13
P010031S665Amplia/Claria/Compia MRI CRT-D, Ampla/Claria/Compia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Viva Quad S/XT CRT-D,MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-05-03
P010031S664Amplia MRI, Amplia MRI Quad, Brava, Brava Quad, Claria MRI, Claria MRI Quad, Consulta, Protecta, Protecta XT, Viva QuadMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-05-01
P010031S663Amplia, Amplia Brava ,Brava Quad, Claria Claria Quard, Compia, Consulta, Protecta, Viva MRI XT S CRT-DMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-04-16
P010031S654Amplia MRI Quad CRT-D SureScan, Compia MRI Quad CRT-D SureScan, Claria MRI Quad CRT-D SureScan and Implantable DefibrillMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT2019-04-10

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