Product Code: DTB


Products Classified as DTB

780Permanent Pacemaker ElectrodeCardiovascular Permanent Or Temporary Pacemaker Electrode.

Total Product Life Cycle (TPLC) Devices

780Permanent Pacemaker ElectrodeCardiovascular Permanent Or Temporary Pacemaker Electrode.

FDA Consensus Standards

Permanent Pacemaker Electrode [36797]21 CFR §870.3680 🔎
Permanent Pacemaker Electrode [36799]21 CFR §870.3680 🔎

Pre-market Approvals for DTB

P800041ENDOCARDIAL PACEMAKER LEAD W/CARBON TIPPACESETTER SYSTEMS
P850089MODEL 5024 TRANSVENOUS PACING LEADMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
P950024MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695MEDTRONIC Inc.
P930039SUREFIXMedtronic, Inc.
P960004THINLINE II/ FINELINE IIBOSTON SCIENTIFIC
P960013TENDRIL SDXSt Jude Medical
P960030TENDRILL PASSIVE PLUS/AU PLUS DXSt. Jude Medical
P950037PHILOS DR-T PULSE GENERATORBIOTRONIK, INC.
P830061CAPSURE SENSE LEAD MODELSMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
P030005CONTAK RENEWAL TR, MODELS H120, H125GUIDANT CORP.
P960006FLEXTEND LEADS, MODELS 4086, 4087, AND 4088BOSTON SCIENTIFIC
P130012Myopore Sutureless Myocardial Pacing LeadGreatbatch Medical
P120017Myocardial Pacing LeadMEDTRONIC Inc.

Pre-market Notifications for DTB

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBIOTRONIK, INC.
K041809PERMANENT PACING LEAD, MODEL PY2Oscor Inc.
K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor Inc.
K031274MODEL 5071 MYOCARDIAL PACING LEADMEDTRONIC VASCULAR
K031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMETRONIC, INC.
K024053PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJBOscor Inc.
K023803MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESSBIOTRONIK, INC.
K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBIOTRONIK, INC.
K023099AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBPBIOTRONIK, INC.
K021217AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBPBIOTRONIK, INC.
K020669PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJBOscor Inc.
K010281MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBPBIOTRONIK, INC.
K001413ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668BIOTRONIK, INC.
K000763PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051BIOTRONIK, GMBH & CO.
K000029STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADSELA MEDICAL, INC.

Global Unique Device Identification Database

00613994793942permanent pacemaker Electrode
00613994776822permanent pacemaker Electrode
00613994740939permanent pacemaker Electrode
00613994740915permanent pacemaker Electrode
00613994726117permanent pacemaker Electrode
00613994719171permanent pacemaker Electrode
00613994719058permanent pacemaker Electrode
00613994718891permanent pacemaker Electrode
00613994718877permanent pacemaker Electrode
00613994568021permanent pacemaker Electrode
00613994568014permanent pacemaker Electrode
00613994567611permanent pacemaker Electrode
00613994520784permanent pacemaker Electrode
00613994501776permanent pacemaker Electrode
00613994492418permanent pacemaker Electrode

Maude Adverse Events

CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMEDTRONIC SINGAPORE OPERATIONS2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSURE EPICARDIAL LEADMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSURE EPICARDIAL LEADMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX LEADMPRI2020-03-31
CAPSUREFIX LEADMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSURE SPMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSURE SPMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMEDTRONIC SINGAPORE OPERATIONS2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSURE SP NOVUS LEADMPRI2020-03-31
CAPSUREFIX NOVUS MRI SURESCANMPRI2020-03-31
CAPSURE ZMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMEDTRONIC SINGAPORE OPERATIONS2020-03-31
CAPSURE SENSE LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMEDTRONIC SINGAPORE OPERATIONS2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS LEAD MRI SURESCANMPRI2020-03-31
CAPSUREFIX NOVUS MRI SURESCANMPRI2020-03-31

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