FDA.reportPublic FDA data

Dual-chamber implantable pacemaker, rate-responsive

Definition
A battery-powered, hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with pacing leads in or on two chambers of the heart (right atrium and ventricle). It is intended to stimulate the chambers of an abnormal heart, through electrical impulses, to beat in their natural sequence, and to adjust the rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended for defibrillation therapy.
GUDID devices
30
Last updated
2026-07-17 22:01:07

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04035479101299Evia DRBIOTRONIK SE & Co. KG3595242014-08-19
04035479101312Evia DR-TBIOTRONIK SE & Co. KG3595292014-08-19
04035479109776Entovis DRBIOTRONIK SE & Co. KG3654612014-08-19
04035479109790Entovis DR-TBIOTRONIK SE & Co. KG3654632014-08-19
04035479114268Estella DRBIOTRONIK SE & Co. KG3712052014-08-04
04035479114299Estella DR-TBIOTRONIK SE & Co. KG3712072014-08-04
04035479115166Entovis DRBIOTRONIK SE & Co. KG3719912014-08-19
04035479115173Entovis DR-T ProMRIBIOTRONIK SE & Co. KG3719922014-08-19
04035479131791Etrinsa 6 DRBIOTRONIK SE & Co. KG3949282014-12-09
04035479131814Epyra 8 DR-TBIOTRONIK SE & Co. KG3949302014-12-09
04035479131821Etrinsa 8 DR-TBIOTRONIK SE & Co. KG3949312014-12-09
04035479131838Epyra 6 DR-TBIOTRONIK SE & Co. KG3949322014-12-09
04035479131845Etrinsa 6 DR-TBIOTRONIK SE & Co. KG3949332014-12-09
04035479131937Eluna 8 DR-T ProMRIBIOTRONIK SE & Co. KG3949692014-12-09
04035479131944Eluna 8 DRBIOTRONIK SE & Co. KG3949702014-12-09
04035479147648Edora 8 DR-TBIOTRONIK SE & Co. KG4071452017-04-18
04035479147686Evity 6 DR-TBIOTRONIK SE & Co. KG4071492020-09-15
04035479173944Solvia Rise DR-TBIOTRONIK SE & Co. KG4602272023-07-12
04035479173999Amvia Edge DR-TBIOTRONIK SE & Co. KG4601632023-07-12
04035479174026Amvia Sky DR-TBIOTRONIK SE & Co. KG4601602023-07-12
05414734006859Integrity® ST. JUDE MEDICAL, INC.ADx DR2014-10-25
05414734006873Identity® ST. JUDE MEDICAL, INC.DR2014-10-23
05414734006897Identity®ST. JUDE MEDICAL, INC.ADx DR2014-10-23
05414734006927Identity®ST. JUDE MEDICAL, INC.54802014-10-29
05414734009546Victory®ST. JUDE MEDICAL, INC.58102014-10-23
05414734501613Zephyr®ST. JUDE MEDICAL, INC.DR2014-10-23
05414734503617Accent®ST. JUDE MEDICAL, INC.DR RF2014-10-23
05415067055514Zenex MRI™ST. JUDE MEDICAL, INC.PM22832026-01-22
08031527018997BlueSkyMICROPORT CRM SRLTPM020U2023-06-23
08031527019017BlueSkyMICROPORT CRM SRLTPM024U2023-06-23