Product Code: OJX


Products Classified as OJX

1070Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode

Total Product Life Cycle (TPLC) Devices

1070Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode

FDA Consensus Standards

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode [36797]21 CFR Unclassified 🔎
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode [33890]21 CFR Unclassified 🔎
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode [36791]21 CFR Unclassified 🔎

Pre-market Approvals for OJX

P030054QUICKFLEX OF LEFT HEART LEADSSt. Jude Medical
P010015CONSULTA CRT-P, C4TR01 AND SYNCRA CRT-P, C2TR01MEDTRONIC Inc.
P050023COROX OTW 75-UP STEROID LEAD, COROS OTW 85-UP STEROID LEADBIOTRONIK, INC.
P010012ACUITY SPIRAL LEAD MODELSBoston Scientific Corp.
P050046Acuity Steerable Lead SystemGUIDANT CORP.
P080006Attain Ability LeadMEDTRONIC Inc.
P060039Attain StarFix LeadMEDTRONIC Inc.

Global Unique Device Identification Database

00613994719133Drug eluting permanent left ventricular (lv) pacemaker electrode
00613994719096Drug eluting permanent left ventricular (lv) pacemaker electrode
00613994469724Drug eluting permanent left ventricular (lv) pacemaker electrode
00613994308658Drug eluting permanent left ventricular (lv) pacemaker electrode
00643169002487Drug eluting permanent left ventricular (lv) pacemaker electrode
00643169860131Drug eluting permanent left ventricular (lv) pacemaker electrode
00643169860124Drug eluting permanent left ventricular (lv) pacemaker electrode
00643169860025Drug eluting permanent left ventricular (lv) pacemaker electrode
00643169601864Drug eluting permanent left ventricular (lv) pacemaker electrode
00643169601857Drug eluting permanent left ventricular (lv) pacemaker electrode
00643169601789Drug eluting permanent left ventricular (lv) pacemaker electrode
00643169590656Drug eluting permanent left ventricular (lv) pacemaker electrode
00643169590649Drug eluting permanent left ventricular (lv) pacemaker electrode
00643169590632Drug eluting permanent left ventricular (lv) pacemaker electrode
00643169590588Drug eluting permanent left ventricular (lv) pacemaker electrode

Maude Adverse Events

SENTUS PROMRI OTW QP L-85/49BIOTRONIK SE & CO. KG2020-03-31
ATTAIN STARFIX LEADMPRI2020-03-31
ATTAIN PERFORMA MRI SURESCANMPRI2020-03-31
ATTAIN ABILITY MRI SURESCANMPRI2020-03-31
SENTUS PROMRI OTW QP L-85/49BIOTRONIK SE & CO. KG2020-03-31
SENTUS PROMRI OTW QP L-85/49BIOTRONIK SE & CO. KG2020-03-31
SENTUS PROMRI OTW QP S-85/49BIOTRONIK SE & CO. KG2020-03-31
SENTUS PROMRI OTW QP S-85/49BIOTRONIK SE & CO. KG2020-03-31
ATTAIN PERFORMA MRI SURESCANMPRI2020-03-31
QUICKFLEX LV LEADST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
ATTAIN PERFORMA MRI SURESCANMPRI2020-03-31
QUARTET LEAD DOUBLE BEND, 86 CMST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
ATTAIN STABILITY QUAD MRI SURESCANMPRI2020-03-31
ATTAIN PERFORMA STRAIGHT MRI SURESCANMPRI2020-03-31
ATTAIN PERFORMA S MRI SURESCANMPRI2020-03-31
ATTAIN ABILITY MRI SURESCANMPRI2020-03-30
QUICKFLEX XL LV LEADST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
QUARTET LEAD DOUBLE BEND, 86 CMST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
COROX OTW-L 85-BPBIOTRONIK SE & CO. KG2020-03-30
SENTUS PROMRI OTW QP L-75/49BIOTRONIK SE & CO. KG2020-03-30
ATTAIN PERFORMA MRI SURESCANMPRI2020-03-30
QUICKSITE LVST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-30
ATTAIN PERFORMA S MRI SURESCANMPRI2020-03-30
QUARTET LEAD DOUBLE BEND, 86 CMST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-30
ATTAIN ABILITY MRI SURESCANMPRI2020-03-30
QUICKFLEX LV LEADST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
ATTAIN STABILITY QUAD MRI SURESCANMPRI2020-03-29
ATTAIN PERFORMA S MRI SURESCANMPRI2020-03-29
ATTAIN PERFORMA S MRI SURESCANMPRI2020-03-29
ATTAIN PERFORMA STRAIGHT MRI SURESCANMPRI2020-03-29
ATTAIN PERFORMA S MRI SURESCANMPRI2020-03-28
ATTAIN PERFORMA S MRI SURESCANMPRI2020-03-28
ATTAIN PERFORMA S MRI SURESCANMPRI2020-03-28
ATTAIN PERFORMA S MRI SURESCANMPRI2020-03-28
QUARTET LEAD DOUBLE BEND, 86 CMST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-27
ATTAIN PERFORMA MRI SURESCANMPRI2020-03-27
QUICKFLEX MICRO LV LEADST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-27
ATTAIN PERFORMA MRI SURESCANMPRI2020-03-27
ATTAIN PERFORMA S MRI SURESCANMPRI2020-03-26
ATTAIN PERFORMA MRI SURESCANMPRI2020-03-26
ATTAIN PERFORMA STRAIGHT MRI SURESCANMPRI2020-03-26
ATTAIN STABILITY QUAD MRI SURESCANMPRI2020-03-26
QUICKFLEX LV LEADST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-26
ATTAIN ABILITY MRI SURESCANMPRI2020-03-26
QUICKFLEX MICRO LV LEADST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-26
ATTAIN PERFORMA S MRI SURESCANMPRI2020-03-26
ATTAIN PERFORMA MRI SURESCANMPRI2020-03-26
ATTAIN PERFORMA MRI SURESCANMPRI2020-03-26
ATTAIN PERFORMA STRAIGHT MRI SURESCANMPRI2020-03-26
ATTAIN PERFORMA STRAIGHT MRI SURESCANMPRI2020-03-26
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