FDA.reportPublic FDA data

Single-chamber implantable pacemaker, rate-responsive

Definition
A battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended to generate and conduct electrical impulses to an abnormal heart to adjust its 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 to provide defibrillation therapy.
GUDID devices
28
Last updated
2026-07-17 22:01:07

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04035479101336Evia SRBIOTRONIK SE & Co. KG3595312014-08-19
04035479101350Evia SR-TBIOTRONIK SE & Co. KG3595332014-08-19
04035479109837Entovis SR-TBIOTRONIK SE & Co. KG3654672014-08-19
04035479114220Estella SR-TBIOTRONIK SE & Co. KG3712002014-08-04
04035479115180Entovis SRBIOTRONIK SE & Co. KG3719932014-08-19
04035479115197Entovis SR-TBIOTRONIK SE & Co. KG3719942014-08-19
04035479131869Epyra 8 SR-TBIOTRONIK SE & Co. KG3949352014-12-09
04035479131876Etrinsa 8 SR-TBIOTRONIK SE & Co. KG3949362014-12-09
04035479131883Epyra 6 SR-TBIOTRONIK SE & Co. KG3949372014-12-09
04035479131890Etrinsa 6 SR-TBIOTRONIK SE & Co. KG3949382014-12-09
04035479131913Etrinsa 6 SRBIOTRONIK SE & Co. KG3949402014-12-09
04035479131951Eluna 8 SR-T ProMRIBIOTRONIK SE & Co. KG3949712014-12-09
04035479131968Eluna 8 SRBIOTRONIK SE & Co. KG3949722014-12-09
04035479147761Edora 8 SR-TBIOTRONIK SE & Co. KG4071572017-04-18
04035479173937Solvia Rise SR-TBIOTRONIK SE & Co. KG4602282023-07-12
04035479173982Amvia Edge SR-TBIOTRONIK SE & Co. KG4601642023-07-12
04035479174019Amvia Sky SR-TBIOTRONIK SE & Co. KG4601612023-07-12
05414734006712Verity®ST. JUDE MEDICAL, INC.ADx XL SC2014-10-23
05414734006767Verity®ST. JUDE MEDICAL, INC.ADx XL SR2014-10-23
05414734006781Integrity® ST. JUDE MEDICAL, INC.ADx SR2014-10-25
05414734006798Identity® ST. JUDE MEDICAL, INC.SR2014-10-23
05414734006804Identity®ST. JUDE MEDICAL, INC.51802014-10-23
05414734009539Victory®ST. JUDE MEDICAL, INC.SR2014-10-23
05414734501606Zephyr®ST. JUDE MEDICAL, INC.SR2014-10-23
05415067055507Zenex MRI™ST. JUDE MEDICAL, INC.PM12832026-01-22
08031527019000BlueSkyMICROPORT CRM SRLTPM021U2023-06-23
08031527019024BlueSkyMICROPORT CRM SRLTPM025U2023-06-23
00763000316709Azure™ XT SR MRI SureScan™MEDTRONIC, INC.W1SR012021-02-25