Product Code: NIK


Products Classified as NIK

1045Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)

Total Product Life Cycle (TPLC) Devices

1045Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)

FDA Consensus Standards

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) [36797]21 CFR Unclassified 🔎
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) [37688]21 CFR Unclassified 🔎
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) [36796]21 CFR Unclassified 🔎

Pre-market Approvals for NIK

P880086AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERSSt. Jude Medical, Inc.
P910023CADENCE/CURRENT FAMILY OF ICDSSt. Jude Medical
P000009BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'SBIOTRONIK, INC.
P970013MICRONYSt. Jude Medical, Inc.
P030035ANTHEM RF CRT-PSSt. Jude Medical, Inc.
P050023Iperia 7 HF-T (DF-1) Iperia 7 HF-T (DF4) Inventra 7 HF-T (DF-1) Inventra 7 HF-T (DF4) Defibrillator, Automatic ImplantabBIOTRONIK, INC.
P030054Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps)St. Jude Medical
P010031CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATIONMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
P010012ACUITY X4 E24 Molding NOR OptimizationBoston Scientific Corp.
P060027Cardiac Resynchronization Therapy DefibrillatorMicroPort CRM USA Inc.

Global Unique Device Identification Database

00613994763273Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
00613994714800Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
00613994714718Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
00613994714695Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
00613994714626Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
00613994714602Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
00613994714589Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
00613994714572Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
00613994678171Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
00613994678140Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
00613994677884Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
00613994677853Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
00613994446916Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
00613994446640Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
00613994446633Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Maude Adverse Events

UNIFY ASSURA CRT-D RF HVST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-30
QUADRA ALLURE MP RF CRT-PST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-30
UNIFY ASSURA CRT-D RF HVST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-30
QUARTETST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-30
QUADRA ASSURA MP ICDST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-30
DYNAGEN X4 CRT-DBOSTON SCIENTIFIC CORPORATION2019-11-30
QUADRA ASSURA MP ICDST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-29
QUADRA ASSURA MP ICDST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-29
QUARTETST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-29
QUADRA ASSURA MP ICDST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-29
QUARTET LEAD SMALL-S, 86 CMST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-28
UNIFY ASSURA CRT-D RF HVST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-28
QUADRA ASSURA MP ICDST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-28
UNIFY ASSURA CRT-D RF HVST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
QUADRA ASSURA MP ICDST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-27
QUADRA ASSURA MP ICDST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
UNIFY ASSURA CRT-D RF HVST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
QUARTET LEAD SMALL-S, 86 CMST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
QUADRA ASSURA MP ICDST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
QUARTETST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
UNIFY ASSURA CRT-D RF HVST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
QUADRA ASSURA MP ICDST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
QUADRA ASSURA MP ICDST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-27
ALLURE QUADRA RF CRT-PST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-27
QUADRA ASSURA MP ICDST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-27
UNIFY ASSURA CRT-D RF HVST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
QUARTET LEAD SMALL-S, 86 CMST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
CLARIA MRI QUAD CRT-D SURESCANMEDTRONIC EUROPE SARL2019-11-27
DYNAGEN X4 CRT-DBOSTON SCIENTIFIC CORPORATION2019-11-27
CLARIA MRI QUAD CRT-D SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2019-11-27
QUARTETST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
QUARTETST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
VIVA? XT CRT-DMEDTRONIC PUERTO RICO OPERATIONS CO.2019-11-27
CLARIA MRI CRT-D SURESCANMEDTRONIC EUROPE SARL2019-11-27
QUADRA ASSURA ICDABBOTT2019-11-27
AMPLIA MRI QUAD CRT-D SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2019-11-27
QUARTETST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
QUADRA ASSURA MP ICDST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
QUADRA ALLURE MP RF CRT-PABBOTT2019-11-27
VIVA? XT CRT-DMEDTRONIC PUERTO RICO OPERATIONS CO.2019-11-27
VIVA? XT CRT-DMEDTRONIC PUERTO RICO OPERATIONS CO.2019-11-27
QUADRA ASSURA MP ICDABBOTT2019-11-27
QUARTET LEAD SMALL-S, 86 CMST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
VIVA? QUAD XT CRT-DMEDTRONIC PUERTO RICO OPERATIONS CO.2019-11-27
CLARIA MRI QUAD CRT-D SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2019-11-27
CLARIA MRI QUAD CRT-D SURESCANMEDTRONIC EUROPE SARL2019-11-27
QUADRA ASSURA DDQP+ABBOTT2019-11-27
CLARIA MRI QUAD CRT-D SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2019-11-27
VIVA? XT CRT-DMEDTRONIC PUERTO RICO OPERATIONS CO.2019-11-27
QUADRA ASSURA MP ICDABBOTT2019-11-27

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