Product Code: NVZ


Products Classified as NVZ

1060Pulse Generator, Permanent, Implantable

Total Product Life Cycle (TPLC) Devices

1060Pulse Generator, Permanent, Implantable

FDA Consensus Standards

Pulse Generator, Permanent, Implantable [36797]21 CFR Unclassified 🔎
Pulse Generator, Permanent, Implantable [37688]21 CFR Unclassified 🔎

Pre-market Approvals for NVZ

P900070META AND TEMPO PACEMAKERSST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
P960013OPTISENSE MODEL 1699T/TC LEADSSt Jude Medical
P880086AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERSSt. Jude Medical, Inc.
P910023CADENCE ICD SYSTEMSt. Jude Medical
P010015SYNCRA/CONSULTA CRT-PMEDTRONIC Inc.
P950029REPLY/ESPIRIT PACEMAKERMicroPort CRM USA Inc.
P010031BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICDM INSYNC III MARQUISMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
P950037EVIA FAMILY OF PACEMAKERSBIOTRONIK, INC.
P970012MEDTRONIC.KAPPA 400 SERIES PACEMAKERSMEDTRONIC Inc.
P890003CareLink SmartSync Base, Patient Connector, Host App, PSA App, Common App, and CareLink SmartSync Platform AppMedtronic, Inc.
P980035CareLink SmartSync Azure Astra App and Azure Astra DR/SR/XT MRI SureScan IPGsMEDTRONIC Inc.

Global Unique Device Identification Database

00613994952431Pulse generator, permanent, implantable
00613994910387Pulse generator, permanent, implantable
00613994763327Pulse generator, permanent, implantable
00613994763310Pulse generator, permanent, implantable
00613994713667Pulse generator, permanent, implantable
00613994614742Pulse generator, permanent, implantable
00613994223807Pulse generator, permanent, implantable
00613994222176Pulse generator, permanent, implantable
00613994222169Pulse generator, permanent, implantable
00613994222107Pulse generator, permanent, implantable
00613994222077Pulse generator, permanent, implantable
00613994222060Pulse generator, permanent, implantable
00643169107052Pulse generator, permanent, implantable
00643169102101Pulse generator, permanent, implantable
00643169102095Pulse generator, permanent, implantable

Maude Adverse Events

FORTIFY ASSURA DR ICD, USST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
ZEPHYR XL DRST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
FORTIFY ASSURA DR ICD, USST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
ASSURITY RF DRST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
ELLIPSE DRST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
ELUNA 8 DR-T PROMRIBIOTRONIK SE & CO. KG2020-03-31
ELLIPSE DRST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
FORTIFY VR, U1.6 SJ4 USST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-31
ELLIPSE DR ICDST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
FORTIFY DR, U1.6 DF1 USST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
ZEPHYR XL DRST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-31
VERSA IPGMEDTRONIC MED REL MEDTRONIC PUERTO RICO2020-03-31
MEDTRONIC IPGMEDTRONIC, INC.2020-03-31
ADVISA MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
ENPULSEMEDTRONIC EUROPE SARL2020-03-31
ADVISA SR MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
ADVISA MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
AZURE XT DR MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
AZURE XT DR MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
AZURE XT DR MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
AZURE XT DR MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
AZURE XT DR MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
SENSIA IPGMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
ADAPTAMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
ADAPTAMEDTRONIC MED REL MEDTRONIC PUERTO RICO2020-03-31
MEDTRONIC IPGMEDTRONIC, INC.2020-03-31
ELLIPSE VRST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
AZURE XT SR MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
AZURE XT DR MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
AZURE XT DR MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
FORTIFY ASSURA DR ICD, USST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
FORTIFY DR, U1.6 SJ4 USST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-30
ACCENT DR RF PACEMAKERST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
CD2257-40Q FORTIFY ASSURA DR ICD_IDE_USST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
ASSURITY RF DRST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
ASSURITY RF DRST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
FORTIFY ASSURA DR ICD, USST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
ASTRA XT DR MRI SURESCANMEDTRONIC EUROPE SARL2020-03-30
ELLIPSE DRST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
ASSURITY SR RFST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
FORTIFY VR, U1.6 DF1 USST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
ZEPHYR DRST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
FORTIFY ASSURA DR ICD, USST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
ZEPHYR XL DRST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-30
CD2257-40 FORTIFY ASSURA DR ICD_IDE_USST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
FORTIFY ASSURA DR ICD, USST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-30
MYCARELINK PATIENT MONITORPLEXUS MANUFACTURING SDN. BHD2020-03-30
ZEPHYR XL SRST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
FORTIFY ASSURA DR ICD, USST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
FORTIFY ASSURA DR ICD, USST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30

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