Product Code: NKE


Products Classified as NKE

1053Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)

Total Product Life Cycle (TPLC) Devices

1053Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)

FDA Consensus Standards

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) [36797]21 CFR Unclassified 🔎
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) [37688]21 CFR Unclassified 🔎
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) [36796]21 CFR Unclassified 🔎

Pre-market Approvals for NKE

P890003CARELINK MONITOR MODELS 2490G/2491DDMAMedtronic, Inc.
P010031CONCERTO II CRT-D,MAXIMO II CRT-D,CONSULTA CRT-D,CONSULTA CRT-D DF4,MAXIMO II CRT-D DF4MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
P010015CONSULTA CRT-P, SYNCRA CRT-PMEDTRONIC Inc.
P030035Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps)St. Jude Medical, Inc.
P030005INVIVE, INTUA, VISIONIST and VALITUDE (CRT-P Resynchronization s)GUIDANT CORP.
P070008Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)BIOTRONIK, INC.

Global Unique Device Identification Database

00613994753304Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
00643169891456Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
00643169891449Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
00643169891432Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
00643169891425Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
00643169891418Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
00643169891401Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
00643169735682Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
00643169735675Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
00643169735668Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
00643169735651Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
00643169735644Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
00643169735637Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
00643169351905Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
00802526559471Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Maude Adverse Events

VISIONIST X4 CRT-PBOSTON SCIENTIFIC CORPORATION2020-03-31
QUADRA ALLURE MP CRT-PST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-31
VALITUDE CRT-PBOSTON SCIENTIFIC CORPORATION2020-03-30
EDORA 8 HF-T QPBIOTRONIK SE & CO. KG2020-03-30
PERCEPTA QUAD CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-30
PERCEPTA QUAD CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-29
SOLARA QUAD CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-28
VALITUDE X4 CRT-PBOSTON SCIENTIFIC CORPORATION2020-03-26
EVIA HF-TBIOTRONIK SE & CO. KG2020-03-26
SOLARA QUAD CRT-P MRI SURESCANMEDTRONIC EUROPE SARL2020-03-24
PERCEPTA QUAD CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-23
PERCEPTA QUAD CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-23
QUADRA ALLURE MP CRT-PST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-22
QUADRA ALLURE MP CRT-PST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-22
PERCEPTA QUAD CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-21
SERENA QUAD CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-21
EDORA 8 HF-T QPBIOTRONIK SE & CO. KG2020-03-20
SOLARA CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-19
QUADRA ALLURE MP CRT-PST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-18
ANTHEM RF CRT-PST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-18
PERCEPTA QUAD CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-17
SERENA CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-17
QUADRA ALLURE MP CRT-PST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-16
PERCEPTA CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-14
SOLARA CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-14
SERENA CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-13
PERCEPTA CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-13
SOLARA CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-13
SOLARA CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-13
SERENA CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-13
ANTHEM RF CRT-PST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-12
QUADRA ALLURE MP CRT-PST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-12
PERCEPTA QUAD CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-12
SOLARA QUAD CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-12
PERCEPTA QUAD CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-11
VIVA CRT-PMEDTRONIC EUROPE SARL2020-03-10
QUADRA ALLURE MP CRT-PST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-10
PERCEPTA QUAD CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-10
VALITUDE X4 CRT-PBOSTON SCIENTIFIC CORPORATION2020-03-10
VISIONIST CRT-PBOSTON SCIENTIFIC CORPORATION2020-03-09
SOLARA QUAD CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-09
PERCEPTA QUAD CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-09
VIVA CRT-PMEDTRONIC EUROPE SARL2020-03-06
PERCEPTA QUAD CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-05
QUADRA ALLURE MP CRT-PST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-04
EDORA 8 HF-T QPBIOTRONIK SE & CO. KG2020-03-03
PERCEPTA CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-03
SOLARA QUAD CRT-P MRI SURESCANMEDTRONIC EUROPE SARL2020-03-03
ANTHEM RF CRT-PST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-03
PERCEPTA QUAD CRT-P MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-03

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