Product Code: NVY


Products Classified as NVY

1059Permanent Defibrillator Electrodes

Total Product Life Cycle (TPLC) Devices

1059Permanent Defibrillator Electrodes

FDA Consensus Standards

Permanent Defibrillator Electrodes [36797]21 CFR Unclassified 🔎
Permanent Defibrillator Electrodes [33890]21 CFR Unclassified 🔎
Permanent Defibrillator Electrodes [36791]21 CFR Unclassified 🔎
Permanent Defibrillator Electrodes [36799]21 CFR Unclassified 🔎

Pre-market Approvals for NVY

P020030STELIX II ENDOCARDIAL PACING LEADSMicroPort CRM USA Inc.
P960004FINELINE II & THINLINE IIBOSTON SCIENTIFIC
P960030PASSIVE PLUS/ISOFLEX S/ISOFLEX P/ISOFLEX OPTIM LEADSSt. Jude Medical
P050046ACUITY STEERABLEGUIDANT CORP.
P960006SWEET TIP RX/FLEXTENDBOSTON SCIENTIFIC
P930039CAPSUREFIX NOVUS/VITATRONMedtronic, Inc.
P850089CAPSUREMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
P950024CAPSURE EPICARDIAL PACING LEAD DRUG COMBINATIONMEDTRONIC Inc.
P910073ENDOTAK RELIANCE IS-I PASSIVE FIXATIONBOSTON SCIENTIFIC
P060039ATTAIN STARFIXMEDTRONIC Inc.
P030036SELECTSECURE LEAD, MODEL 3830MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
P950022OPTISURESt. Jude Medical, Inc.
P980023KAINOX VCS,SLX 58/11-BP,SLX 58/13-BP,SLX 58/14-BP,SLX 58/15-BP,SLX 58/17-BP,LINOX S 65,LINOX S 75, LINOX T 65,LINOX T75,BIOTRONIK, INC.
P830061CAPSURE SENSE, SP, SP NOVUS LEADS, VITATRON CRYSTALLINE & EXCELLENCE PS LEADSMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
P960013TENDRIL SDX, ST, STS, AND OPTISCIENSE L V LEADSSt Jude Medical

Global Unique Device Identification Database

00613994808004Permanent defibrillator electrodes
00613994776853Permanent defibrillator electrodes
00613994740922Permanent defibrillator electrodes
00613994740908Permanent defibrillator electrodes
00613994718853Permanent defibrillator electrodes
00613994718839Permanent defibrillator electrodes
00613994657374Permanent defibrillator electrodes
00613994618177Permanent defibrillator electrodes
00613994492432Permanent defibrillator electrodes
00613994492388Permanent defibrillator electrodes
00613994492364Permanent defibrillator electrodes
00613994446350Permanent defibrillator electrodes
00613994446114Permanent defibrillator electrodes
00613994446107Permanent defibrillator electrodes
00613994446091Permanent defibrillator electrodes

Maude Adverse Events

RIATA ACTIVE FIXATIONST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-30
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-30
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-30
ENDOTAK RELIANCE GBOSTON SCIENTIFIC CORPORATION2019-11-30
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-29
DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-29
OPTISURE ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-29
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-29
ISOFLEX OPTIM LEADST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-29
ISOFLEX OPTIM LEADST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-29
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
RIATA ACTIVE FIXATIONST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
OPTISURE ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
RIATA ACTIVE FIXATIONST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-27
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-27
ISOFLEX OPTIM LEADABBOTT2019-11-27
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
ISOFLEX OPTIM LEADST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
OPTISURE ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-27
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORABBOTT2019-11-27
SPRINT QUATTRO SECURE MRI SURESCANMPRI2019-11-27
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORABBOTT2019-11-27
RIATA ACTIVE FIXATIONST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
ISOFLEX OPTIM LEADST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
SPRINT QUATTRO SECURE MRI SURESCANMPRI2019-11-27
ISOFLEX OPTIM LEADST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-27
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-27
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-27
OPTISURE ACTIVE FIXATIONST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-27
RIATA ST ACTIVE FIXATIONST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-26
RIATA ACTIVE FIXATIONST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-26
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-26
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTORST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-11-26
ISOFLEX OPTIM LEADABBOTT2019-11-26
SPRINT QUATTRO SECURE MRI SURESCANMPRI2019-11-26
LINOX SMART T 65BIOTRONIK SE & CO. KG2019-11-26
PROTEGO DF-1 PROMRI S 65BIOTRONIK SE & CO. KG2019-11-26
LINOX SMART PROMRI S 65BIOTRONIK SE & CO. KG2019-11-26
ISOFLEX OPTIM LEADST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-11-26
RIATA ACTIVE FIXATIONABBOTT2019-11-26
SPRINT QUATTRO SECURE MRI SURESCANMPRI2019-11-26

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.