FDA.reportPublic FDA data

Endocardial defibrillation lead

Definition
A sterile, 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
215
Last updated
2020-07-29 06:17:21

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04035479139971Plexa ProMRI SD 60/16BIOTRONIK SE & Co. KG4022612020-07-21
04035479140014Plexa ProMRI S 60BIOTRONIK SE & Co. KG4022652020-07-21
04035479150952Plexa ProMRI DF-1 S 60BIOTRONIK SE & Co. KG4139962020-07-21
04035479150983Plexa ProMRI DF-1 SD 60/16BIOTRONIK SE & Co. KG4139992020-07-21
20802526563229LIGATURE SLEEVEOscor Inc.664760-3022016-07-07
20885672008349Ligature SleeveOscor Inc.664760-3032017-11-18
05414734502085Durata™ST. JUDE MEDICAL, INC.71202017-04-10
05414734502092Durata™ST. JUDE MEDICAL, INC.71202017-01-24
05414734502108Durata™ST. JUDE MEDICAL, INC.7120/752017-02-02
05414734502115Durata™ST. JUDE MEDICAL, INC.7121-602017-04-10
05414734502122Durata™ST. JUDE MEDICAL, INC.7121-652017-02-02
05414734502139Durata™ST. JUDE MEDICAL, INC.7121/752017-02-02
05414734502146Durata™ST. JUDE MEDICAL, INC.71222017-02-02
05414734502153Durata™ST. JUDE MEDICAL, INC.71222017-02-02
05414734502160Durata™ST. JUDE MEDICAL, INC.7122/752017-02-02
05414734502436Durata™ST. JUDE MEDICAL, INC.7170-652017-02-02
05414734502443Durata™ST. JUDE MEDICAL, INC.7171-652017-02-02
05414734502818Durata™ST. JUDE MEDICAL, INC.7120Q-582017-04-10
05414734503037Durata™ST. JUDE MEDICAL, INC.7120Q-522017-02-02
05414734503167Durata™ST. JUDE MEDICAL, INC.7121Q-582017-04-10
05414734503174Durata™ST. JUDE MEDICAL, INC.7122Q-582017-05-05
05414734503204Durata™ST. JUDE MEDICAL, INC.7120Q-652017-04-10
05414734503211Durata™ST. JUDE MEDICAL, INC.7121Q-522017-04-10
05414734503228Durata™ST. JUDE MEDICAL, INC.7121Q-652017-04-10
05414734503242Durata™ST. JUDE MEDICAL, INC.7170Q-522017-04-10
05414734503259Durata™ST. JUDE MEDICAL, INC.7170Q-582017-04-10
05414734503266Durata™ST. JUDE MEDICAL, INC.7170Q-652017-04-10
05414734503273Durata™ST. JUDE MEDICAL, INC.7171Q-522017-04-10
05414734503280Durata™ST. JUDE MEDICAL, INC.7171Q-582017-04-10
05414734503297Durata™ST. JUDE MEDICAL, INC.7171Q-652017-04-10
05414734503341Durata™ST. JUDE MEDICAL, INC.7122Q-652017-04-10
05414734503730Durata™ST. JUDE MEDICAL, INC.7122Q-522017-04-10
05414734505109Durata™ST. JUDE MEDICAL, INC.7130-752017-02-02
05414734505116Durata®ST. JUDE MEDICAL, INC.7131-602017-01-25
05414734505123Durata®ST. JUDE MEDICAL, INC.7131-652017-01-25
05414734505130Durata™ST. JUDE MEDICAL, INC.7131-752017-02-02
05414734507165OPTISURE™ST. JUDE MEDICAL, INC.LDA210-602017-04-10
05414734507172Optisure™ST. JUDE MEDICAL, INC.LDA2102017-04-10
05414734507189OPTISURE™ST. JUDE MEDICAL, INC.LDA210-752017-04-10
05414734507196OPTISURE¿™ST. JUDE MEDICAL, INC.LDA220-602017-04-10
05414734507202Optisure™ST. JUDE MEDICAL, INC.LDA2202017-04-10
05414734507219OPTISURE¿™ST. JUDE MEDICAL, INC.LDA220-752017-04-10
05414734507226OPTISURE™¿ST. JUDE MEDICAL, INC.LDA230-602017-04-10
05414734507233OPTISURE¿™ST. JUDE MEDICAL, INC.LDA230-652017-04-10
05414734507240OPTISURE¿™ST. JUDE MEDICAL, INC.LDA230-752017-02-03
05414734507257OPTISURE™ST. JUDE MEDICAL, INC.LDP220-602017-02-03
05414734507264OPTISURE™ST. JUDE MEDICAL, INC.LDP220-652017-02-03
05414734507271OPTISURE™ST. JUDE MEDICAL, INC.LDP220-752017-02-03
05414734507288OPTISURE™ST. JUDE MEDICAL, INC.LDP230-602017-02-03
05414734507295OPTISURE™ST. JUDE MEDICAL, INC.LDP230-652017-02-03
05414734507301OPTISURE™ST. JUDE MEDICAL, INC.LDP230-752017-02-03
05414734507318OPTISURE™ST. JUDE MEDICAL, INC.LDA210Q-522017-02-03
05414734507325OPTISURE™ST. JUDE MEDICAL, INC.LDA210Q-582017-02-03
05414734507332OPTISURE™ST. JUDE MEDICAL, INC.LDA210Q-652017-02-03
05414734507349OPTISURE™ST. JUDE MEDICAL, INC.LDA220Q-522017-02-03
05414734507356OPTISURE™ST. JUDE MEDICAL, INC.LDA220Q-582017-04-10
05414734507363OPTISURE™ST. JUDE MEDICAL, INC.LDA220Q-652017-02-03
05414734507370OPTISURE¿™ST. JUDE MEDICAL, INC.LDA230Q-522017-02-03
05414734507387OPTISURE™ST. JUDE MEDICAL, INC.LDA230Q-582017-04-10
05414734507394OPTISURE™ST. JUDE MEDICAL, INC.LDA230Q-652017-02-03
05414734507431OPTISURE™ST. JUDE MEDICAL, INC.LDP220Q-522017-04-10
05414734507448OPTISURE™ST. JUDE MEDICAL, INC.LDP220Q-582017-04-10
05414734507455OPTISURE™ST. JUDE MEDICAL, INC.LDP220Q-652017-04-10
05414734507462OPTISURE™ST. JUDE MEDICAL, INC.LDP230Q-522017-04-10
05414734507479OPTISURE™ST. JUDE MEDICAL, INC.LDP230Q-582017-04-10
05414734507486OPTISURE™ST. JUDE MEDICAL, INC.LDP230Q-652017-04-10
H75871306009Durata®ST. JUDE MEDICAL, INC.7130-602014-09-29
00802526085505ENDOTAK RELIANCE® SBOSTON SCIENTIFIC CORPORATION01282014-09-24
00802526085789ENDOTAK RELIANCE®BOSTON SCIENTIFIC CORPORATION01472014-09-24
00802526085918ENDOTAK RELIANCE®BOSTON SCIENTIFIC CORPORATION01482014-09-24
00802526373282ENDOTAK RELIANCE® SGBOSTON SCIENTIFIC CORPORATION01702014-09-24
00802526373374ENDOTAK RELIANCE® SGBOSTON SCIENTIFIC CORPORATION01712014-09-24
00802526373640ENDOTAK RELIANCE® GBOSTON SCIENTIFIC CORPORATION01742014-09-24
00802526373732ENDOTAK RELIANCE® GBOSTON SCIENTIFIC CORPORATION01752014-09-24
00802526376726ENDOTAK RELIANCE® GBOSTON SCIENTIFIC CORPORATION01762014-09-24
00802526376818ENDOTAK RELIANCE® GBOSTON SCIENTIFIC CORPORATION01772014-09-24
00802526431289ENDOTAK RELIANCE®BOSTON SCIENTIFIC CORPORATION02652014-09-24
00802526431296ENDOTAK RELIANCE®BOSTON SCIENTIFIC CORPORATION02662014-09-24
00802526431371ENDOTAK RELIANCE® SGBOSTON SCIENTIFIC CORPORATION02822014-09-24
00802526431388ENDOTAK RELIANCE® SGBOSTON SCIENTIFIC CORPORATION02832014-09-24