FDA.reportPublic FDA data

Endocardial defibrillation lead

Definition
An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, intended to function as an electrical conductor to transmit defibrillation impulses from an implanted cardioverter-defibrillator (ICD) [automatic implantable cardioverter-defibrillator (AICD)] to the endocardium of the right ventricle. It may also be intended to transmit pacing impulses from a cardiac resynchronization therapy (CRT) pulse generator, AICD, or other pacing device. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.
GUDID devices
109
Last updated
2026-10-06 03:50:21

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00802526531101ENDOTAK RELIANCE® SBOSTON SCIENTIFIC CORPORATION01372014-09-24
00802526531118ENDOTAK RELIANCE® SBOSTON SCIENTIFIC CORPORATION01382014-09-24
00802526531125ENDOTAK RELIANCE®BOSTON SCIENTIFIC CORPORATION01572014-09-24
00802526531132ENDOTAK RELIANCE®BOSTON SCIENTIFIC CORPORATION01582014-09-24
04035479144814DH DF4BIOTRONIK SE & Co. KG3791372014-08-20
04035479146160DH IS-1/DF4BIOTRONIK SE & Co. KG4012982017-03-27
05414734505086Durata®ST. JUDE MEDICAL, INC.7130-602014-09-29
00763000643416OmniaSecure™ MRI SureScan™MEDTRONIC, INC.3930M692025-12-19
00763000643430OmniaSecure™ MRI SureScan™MEDTRONIC, INC.3930M742025-12-19
00763000643454OmniaSecure™ MRI SureScan™MEDTRONIC, INC.3930M792025-12-19
00763000643478OmniaSecure™ MRI SureScan™MEDTRONIC, INC.3930M842025-12-19
00763000643539OmniaSecure™ MRI SureScan™MEDTRONIC, INC.3930M642025-12-19
00763000180010Sprint Quattro Secure S™MEDTRONIC, INC.6935522024-11-04
00763000180027Sprint Quattro Secure S™MEDTRONIC, INC.6935752024-11-04
00763000180034Sprint Quattro Secure S™MEDTRONIC, INC.69351002024-11-04
00763000180041Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.6935582024-11-04
00763000180058Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.6935652024-11-04
00763000180119Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.6935M552024-11-04
00763000180126Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.6935M622024-11-04
00763000180133Sprint Quattro Secure S™MEDTRONIC, INC.6935M492024-11-04
00763000180140Sprint Quattro Secure S™MEDTRONIC, INC.6935M722024-11-04
00763000180157Sprint Quattro Secure S™MEDTRONIC, INC.6935M972024-11-04
00763000180232Sprint Quattro Secure™MEDTRONIC, INC.6947752024-11-04
00763000180249Sprint Quattro Secure™MEDTRONIC, INC.69471002024-11-04
00763000180256Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.6947582024-11-04
00763000180263Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.6947652024-11-04
00763000180317Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.6947M552024-11-04
00763000180324Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.6947M622024-11-04
00763000180331Sprint Quattro Secure™MEDTRONIC, INC.6947M492024-11-04
00763000180348Sprint Quattro Secure™MEDTRONIC, INC.6947M722024-11-04
00763000180355Sprint Quattro Secure™MEDTRONIC, INC.6947M972024-11-04
00763000369767Epsila EV™ MRI SureScan™MEDTRONIC, INC.EV2401522023-11-02
00763000369781Epsila EV™ MRI SureScan™MEDTRONIC, INC.EV2401632023-11-02
04035479156442Pamira S 60BIOTRONIK SE & Co. KG4287682023-01-24
04035479156459Pamira S 65BIOTRONIK SE & Co. KG4287692023-01-24
04035479156466Pamira S 75BIOTRONIK SE & Co. KG4287702023-01-24
04035479156473Pamira SD 60/16BIOTRONIK SE & Co. KG4287712023-01-24
04035479156480Pamira SD 65/16BIOTRONIK SE & Co. KG4287722023-01-24
04035479156497Pamira SD 65/18BIOTRONIK SE & Co. KG4287732023-01-24
04035479156503Pamira SD 75/18BIOTRONIK SE & Co. KG4287742023-01-24
04035479156510Pamira S DX 65/15BIOTRONIK SE & Co. KG4287752023-01-24
04035479156527Pamira S DX 65/17BIOTRONIK SE & Co. KG4287762023-01-24
04035479011987Kainox VCS 60BIOTRONIK SE & Co. KG1243252014-08-19
04035479100384Linox Smart SD 60/16BIOTRONIK SE & Co. KG3590652014-08-06
04035479100391Linox Smart SD 65/16BIOTRONIK SE & Co. KG3590662014-08-06
04035479100407Linox Smart SD 65/18BIOTRONIK SE & Co. KG3590672014-08-06
04035479100414Linox Smart SD 75/18BIOTRONIK SE & Co. KG3590682014-08-06
04035479100469Linox Smart TD 65/16BIOTRONIK SE & Co. KG3590732014-08-06
04035479100476Linox Smart TD 65/18BIOTRONIK SE & Co. KG3590742014-08-06
04035479100490Protego TD 65/16BIOTRONIK SE & Co. KG3590762014-08-22
04035479100506ProtegoBIOTRONIK SE & Co. KGTD 65/182014-08-22
04035479100513ProtegoBIOTRONIK SE & Co. KGTD 75/182014-08-22
04035479110017Linox Smart S DX 65/15BIOTRONIK SE & Co. KG3655002014-08-20
04035479110024Linox Smart S DX 65/17BIOTRONIK SE & Co. KG3655012014-08-20
04035479112974Linox Smart S 65BIOTRONIK SE & Co. KG3698182014-08-20
04035479112981Linox Smart S 75BIOTRONIK SE & Co. KG3698192014-08-20
04035479112998Linox Smart T 65BIOTRONIK SE & Co. KG3698202014-08-08
04035479116194Linox Smart S 60BIOTRONIK SE & Co. KG3750122014-08-08
04035479121471Protego S 75BIOTRONIK SE & Co. KG3799682014-08-20
04035479121488Protego S 65BIOTRONIK SE & Co. KG3799692014-08-20
04035479121495Protego S 60BIOTRONIK SE & Co. KG3799702014-08-20
04035479121686Protego T 65BIOTRONIK SE & Co. KG3799672014-08-20
04035479132644DH DF4BIOTRONIK SE & Co. KG3954022014-08-20
04035479133139PlexaBIOTRONIK SE & Co. KGS 602018-10-12
04035479136093Protego SD 60/16BIOTRONIK SE & Co. KG3994082014-08-20
04035479136109ProtegoBIOTRONIK SE & Co. KGSD 65/162014-08-20
04035479136116Protego SD 65/18BIOTRONIK SE & Co. KG3994102014-08-20
04035479136123ProtegoBIOTRONIK SE & Co. KGSD 75/182014-08-20
04035479138516DH IS-1/DF4BIOTRONIK SE & Co. KG4012972017-03-27
04035479139995Plexa ProMRIBIOTRONIK SE & Co. KGSD 65/182017-03-27
04035479140007Plexa ProMRIBIOTRONIK SE & Co. KGSD 75/182018-04-19
04035479140021Plexa ProMRIBIOTRONIK SE & Co. KGS 652017-03-27
04035479140038Plexa ProMRIBIOTRONIK SE & Co. KGS 752017-03-27
04035479143121VOLTABIOTRONIK SE & Co. KG2CT 75/182014-08-19
04035479143138VOLTABIOTRONIK SE & Co. KG1CT 652014-08-19
04035479143145VOLTABIOTRONIK SE & Co. KG2CT 65/162014-08-19
04035479143367VOLTABIOTRONIK SE & Co. KG1CR 602014-08-19
04035479143374VOLTABIOTRONIK SE & Co. KG1CR 652014-08-19
04035479143381VOLTABIOTRONIK SE & Co. KG1CR 752014-08-19
04035479143398VOLTABIOTRONIK SE & Co. KG2CR 60/162014-08-19