Product Code: LWS


Products Classified as LWS

1015Implantable Cardioverter Defibrillator (non-crt)

Total Product Life Cycle (TPLC) Devices

1015Implantable Cardioverter Defibrillator (non-crt)

FDA Consensus Standards

Implantable Cardioverter Defibrillator (Non-Crt) [32150]21 CFR Unclassified 🔎
Implantable Cardioverter Defibrillator (Non-Crt) [36797]21 CFR Unclassified 🔎
Implantable Cardioverter Defibrillator (Non-Crt) [36791]21 CFR Unclassified 🔎
Implantable Cardioverter Defibrillator (Non-Crt) [37688]21 CFR Unclassified 🔎
Implantable Cardioverter Defibrillator (Non-Crt) [36796]21 CFR Unclassified 🔎
Implantable Cardioverter Defibrillator (Non-Crt) [31693]21 CFR Unclassified 🔎

Pre-market Approvals for LWS

P880086AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERSSt. Jude Medical, Inc.
P030035FRONTIER/FRONTIER II / ANTHEM FAMILY OF CRT-PSSt. Jude Medical, Inc.
P030054EPIC HF/ATLAS + HF/PROMOTE/UNIFY FAMILY OF CRT-DSSt. Jude Medical
P010031PROTECTA XT CRT-D, PROTECTA CRT-D, CONSULTA CRT-D, CONCERTO II CRT-D, MAXIMO II CRT-DMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
P050023LUMAX 6/7 AND ILESTO/IFORIA ICD/CRT D FAMILIESBIOTRONIK, INC.
P980049PARADYM VR 8750, PARADYM DR 8750, PARADYM RF CRT-DMicroPort CRM USA Inc.
P920015SPRINT QUATTROMEDTRONIC Inc.
P010012CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, NG3 CRT-D DYNAGEN CRT-D & X4 CRT-D, INOGEN CRT-D & X4 CRT-D. ORIGEN CRTBoston Scientific Corp.
P950022IS4/DF4 Connector Sleeve; Suture Sleeve; Suture Sleeve KitSt. Jude Medical, Inc.
P980016Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, MMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
P910023Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDsSt. Jude Medical
P980023Plexa ProMRI S DX ICD LeadsBIOTRONIK, INC.
P910077LATITUDE NXT Patient Management System, LATITUDE Wave Communicator, LATITUDE Consult Communicator and LATITUDE NXT SysteBOSTON SCIENTIFIC
P960040TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, and PERCIVA (ICD DevBOSTON SCIENTIFIC
P110042Emblem S-ICD, ElectrodeBOSTON SCIENTIFIC CORPORATION

Global Unique Device Identification Database

00613994763303Implantable cardioverter defibrillator (non-CRT)
00613994714701Implantable cardioverter defibrillator (non-CRT)
00613994714619Implantable cardioverter defibrillator (non-CRT)
00613994714596Implantable cardioverter defibrillator (non-CRT)
00613994678188Implantable cardioverter defibrillator (non-CRT)
00613994678164Implantable cardioverter defibrillator (non-CRT)
00613994678157Implantable cardioverter defibrillator (non-CRT)
00613994677891Implantable cardioverter defibrillator (non-CRT)
00613994677877Implantable cardioverter defibrillator (non-CRT)
00613994677860Implantable cardioverter defibrillator (non-CRT)
00613994677846Implantable cardioverter defibrillator (non-CRT)
00613994534583Implantable cardioverter defibrillator (non-CRT)
00613994520937Implantable cardioverter defibrillator (non-CRT)
00613994520890Implantable cardioverter defibrillator (non-CRT)
00613994446619Implantable cardioverter defibrillator (non-CRT)

Maude Adverse Events

FORTIFY ASSURA VR ICD, USST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
SPRINT FIDELISMPRI2020-03-31
SPRINT FIDELISMPRI2020-03-31
SPRINT QUATTRO SECURE S MRI SURESCANMPRI2020-03-31
FORTIFY VR, U1.6 SJ4 IDABBOTT2020-03-31
DURATA STS OPTIM ACTIVE FIXATIONABBOTT2020-03-31
SPRINT QUATTRO SECURE S MRI SURESCANMPRI2020-03-31
SPRINT QUATTRO SECURE S MRI SURESCANMPRI2020-03-31
EVERA MRI XT DR SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
SPRINT QUATTRO SECURE S MRI SURESCANMPRI2020-03-31
INVENTRA 7 VR-T DX PROMRIBIOTRONIK SE & CO. KG2020-03-31
VISIA AF MRI S VR SURESCANMEDTRONIC EUROPE SARL2020-03-31
DURATA STS OPTIM ACTIVE FIXATIONST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-31
SPRINT QUATTRO SECURE MRI SURESCANMPRI2020-03-31
RELIANCE 4-FRONTBOSTON SCIENTIFIC CORPORATION2020-03-31
SPRINT QUATTRO SECURE S MRI SURESCANMPRI2020-03-31
SPRINT FIDELISMPRI2020-03-31
SPRINT QUATTRO SECURE S MRI SURESCANMPRI2020-03-31
SPRINT FIDELISMPRI2020-03-31
SPRINT QUATTRO SECURE S MRI SURESCANMEDTRONIC SINGAPORE OPERATIONS2020-03-31
SPRINT QUATTRO SECURE S MRI SURESCANMPRI2020-03-31
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTERMEDTRONIC, INC.2020-03-31
SPRINT QUATTRO SECURE S MRI SURESCANMEDTRONIC, INC.2020-03-31
SPRINT QUATTRO SECURE MRI SURESCANMPRI2020-03-31
PROTECTA XT DRMEDTRONIC MED REL MEDTRONIC PUERTO RICO2020-03-31
SPRINT FIDELISMPRI2020-03-31
SPRINT QUATTRO SECURE S MRI SURESCANMEDTRONIC SINGAPORE OPERATIONS2020-03-31
EVERA? XT VRMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
SPRINT QUATTRO SECURE S MRI SURESCANMPRI2020-03-31
SPRINTMPRI2020-03-31
SPRINTMPRI2020-03-31
EVERA? XT DRMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
SPRINT QUATTRO SECURE S MRI SURESCANMPRI2020-03-31
SPRINT QUATTRO SECURE MRI SURESCANMPRI2020-03-31
SPRINT QUATTRO SECURE S MRI SURESCANMPRI2020-03-31
EVERA MRI XT VR SURESCANMEDTRONIC EUROPE SARL2020-03-31
SPRINT QUATTRO SECURE MRI SURESCANMPRI2020-03-30
PROTECTA XT VRMEDTRONIC MED REL MEDTRONIC PUERTO RICO2020-03-30
INOGEN MINI ICD DRBOSTON SCIENTIFIC CORPORATION2020-03-30
INTERVENE LEADBOSTON SCIENTIFIC CORPORATION2020-03-30
SUB Q ARRAYBOSTON SCIENTIFIC CORPORATION2020-03-30
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)BOSTON SCIENTIFIC CORPORATION2020-03-30
DYNAGEN MINI ICD VRBOSTON SCIENTIFIC CORPORATION2020-03-30
INOGEN EL ICD VRBOSTON SCIENTIFIC CORPORATION2020-03-30
INOGEN EL ICD DRBOSTON SCIENTIFIC CORPORATION2020-03-30
DYNAGEN EL ICD DRBOSTON SCIENTIFIC CORPORATION2020-03-30
DYNAGEN EL ICD DRBOSTON SCIENTIFIC CORPORATION2020-03-30
DYNAGEN EL ICD DRBOSTON SCIENTIFIC CORPORATION2020-03-30
INOGEN EL ICD DRBOSTON SCIENTIFIC CORPORATION2020-03-30
INOGEN EL ICD DRBOSTON SCIENTIFIC CORPORATION2020-03-30
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.