FDA.reportPublic FDA data

Cardiac resynchronization therapy implantable pacemaker

Definition
A sterile, battery-powered, hermetically-sealed pulse generator, intended to be implanted beneath the skin of the chest in a surgically-created pocket, and used with pacing leads placed in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber) to stimulate the heart to beat at a faster rate when it senses bradycardia and provides cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions to treat symptoms of heart failure (e.g., easy fatigue) and serious heart-rhythm problems [CRT pacemaker (CRT-P)]; it is not intended for defibrillation therapy.
GUDID devices
24
Last updated
2020-10-19 06:38:20

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04035479118358Evia HFBIOTRONIK SE & Co. KG3772062014-08-04
04035479118372Evia HF-TBIOTRONIK SE & Co. KG3772082014-08-04
05414734502948Frontier™ST. JUDE MEDICAL, INC.II2017-02-03
05414734503785ANTHEM™ST. JUDE MEDICAL, INC.PM32102017-04-10
H758PM311001Anthem®ST. JUDE MEDICAL, INC.PM31102014-10-23
05414734507882Allure™ST. JUDE MEDICAL, INC.PM31202017-04-10
05414734507899Allure Quadra™ST. JUDE MEDICAL, INC.PM31402017-04-10
05414734507905Allure™ST. JUDE MEDICAL, INC.PM32222017-04-10
05414734507912Allure Quadra™ST. JUDE MEDICAL, INC.PM32422017-04-10
05414734509084QUADRA ALLURE MP™ST. JUDE MEDICAL, INC.PM31602016-03-23
05414734509091QUADRA ALLURE MP™ST. JUDE MEDICAL, INC.PM32622016-03-23
05414734510080Quadra Allure™ST. JUDE MEDICAL, INC.PM35422019-01-15
05414734510097Quadra Allure MP™ST. JUDE MEDICAL, INC.PM35622019-01-15
00802526536663INTUA™BOSTON SCIENTIFIC CORPORATIONV2722014-09-24
00802526536670INTUA™BOSTON SCIENTIFIC CORPORATIONV2732014-09-24
00802526559389VALITUDE™ CRT-PBOSTON SCIENTIFIC CORPORATIONU1252014-11-11
00802526559402VALITUDE™ X4 CRT-PBOSTON SCIENTIFIC CORPORATIONU1282014-11-11
00802526559426VISIONIST™ CRT-PBOSTON SCIENTIFIC CORPORATIONU2252017-03-09
00802526559457VISIONIST™ CRT-PBOSTON SCIENTIFIC CORPORATIONU2262017-03-09
00802526559471VISIONIST™ X4 CRT-PBOSTON SCIENTIFIC CORPORATIONU2282017-03-09
00643169351905Viva™ CRT-PMEDTRONIC, INC.C6TR012014-09-23
00643169735682Solara™ Quad CRT-P MRI SureScan™MEDTRONIC, INC.W4TR032017-06-18
00613994713667Consulta® CRT-PMEDTRONIC, INC.C4TR012014-09-23
00613994753304Syncra™ CRT-PMEDTRONIC, INC.C2TR012014-09-23