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 QUADRA CRT-D, US MODEL, DF4COMPST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
QUADRA ASSURA CRT-D QUAD RF HVST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
QUADRA ASSURA CRT-D QUAD RF HVST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
QUADRA ASSURA MP ICDABBOTT2020-03-31
QUADRA ASSURA CRT-D QUAD RF HVST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
QUADRA ASSURA MP ICDST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-31
CLARIA MRI CRT-D SURESCANMEDTRONIC EUROPE SARL2020-03-31
UNIFY ASSURA CRT-D RF HVST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-31
CLARIA MRI QUAD CRT-D SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
QUARTETST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
QUARTET LEAD SMALL-S, 86 CMST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-31
QUARTETST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-31
UNIFY ASSURA ICDABBOTT2020-03-31
QUADRA ASSURA (DDQP+)ST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
QUADRA ASSURA ICDST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
INVENTRA 7 HF-T QP DF4 IS4BIOTRONIK SE & CO. KG2020-03-31
INTICA 7 HF-T QP DF-1 IS4 PROMRIBIOTRONIK SE & CO. KG2020-03-31
QUADRA ASSURA MP ICDABBOTT2020-03-31
CLARIA MRI CRT-D SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
CLARIA MRI QUAD CRT-D SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
PROTECTA CRT-DMEDTRONIC EUROPE SARL2020-03-31
QUADRA ASSURA MP ICDST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-31
UNIFY ASSURA ICDST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-31
CLARIA MRI CRT-D SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
QUADRA ASSURA DDQP+ST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
QUADRA ASSURA MP ICDST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
QUADRA ASSURA MP ICDABBOTT2020-03-31
UNIFY ASSURA CRT-D RF HVST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
QUADRA ASSURA MP ICDST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
AMPLIA MRI QUAD CRT-D SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
QUARTETST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
CLARIA MRI QUAD CRT-D SURESCANMEDTRONIC EUROPE SARL2020-03-31
QUARTET LEAD SMALL-S, 86 CMST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-31
QUARTETST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-30
EASYTRAK 2 IS-1BOSTON SCIENTIFIC CORPORATION2020-03-30
EASYTRAK 2 IS-1BOSTON SCIENTIFIC CORPORATION2020-03-30
QUADRA ASSURA MP ICDST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-30
INOGEN CRT-DBOSTON SCIENTIFIC CORPORATION2020-03-30
UNIFY ASSURA CRT-D RF HVST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
QUARTETST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
ALLURE QUADRA RF CRT-PST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
QUARTETST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
QUADRA ASSURA CRT-D QUAD RF HVST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
VIVA? QUAD S CRT-DMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-30
QUARTETABBOTT2020-03-30
PROTECTA CRT-DMEDTRONIC EUROPE SARL2020-03-30
VIVA? QUAD XT CRT-DMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-30
MERLIN PROGRAMMERABBOTT2020-03-30
CLARIA MRI CRT-D SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-30
AMPLIA MRI QUAD CRT-D SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-30

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