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Biotronik, Inc.

945 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
DEXTRUS, SETROX S, TILDA, SAFIO S (P950037/S146)Biotronik, Inc.2015-02-02
LINOX SMART SD, LINOX SMART S, VOLTA 1CR, VOLTA 2CR (P980023/S063)Biotronik, Inc.2015-02-02
SETROX S LEAD, DEXTRUS, TILDA R, SAFIO S. (P950037/S145)Biotronik, Inc.2014-12-03
ELUNA 8 HF-T; ENTOVIS HF, ENTOVIS HF-T, EPYRA 8 HF-T (P070008/S058)Biotronik, Inc.2014-11-21
EURO DR, DRT, SR, SR-T; EFFECTA D, DR, S, SR; ELUNA E DR-T PROMRI, 8 DRPROMRI; ELUNA 8 DR-T PROMRI; ELUNA 8 SR-T PROMRI; (P950037/S144)Biotronik, Inc.2014-11-21
IGOTIS 5 HF-T (DF-4), 7 HF-T (DF-4, LI); IFORIA 7 HF-T (DF4, GB) IIESTO 5 HF-TIESTO 5 HF-T (DF-4) (P050023/S082)Biotronik, Inc.2014-11-21
LUMAX 300/340 & 500/540 DR/DR-T/VR/VR-T ICD'S, LUMAX 540 VR-T DX ICD, KRONOS LV-T, LUMAX 300/340 & 500/540 HF/HF-T CRT-D (P050023/S077)Biotronik, Inc.2014-11-17
ETRINSA 8/6 DR-T/SR-T, ETRINSA 6 DR/SR, EPYRA 8/6 DR-T/SR-T, ELUNA 8 DR-T/SR-T DR/SR PRO MRI PACEMAKERS (P950037/S137)Biotronik, Inc.2014-11-17
ETRINSA 8 HF-T, EPYRA 8 HF-T, ELUNA 8 HF-T CRT-P'S (P070008/S053)Biotronik, Inc.2014-11-17
BELOS & LEXOS DR/DR-T/VR/VR-T ICD'S, LUMOS DR-T/VR-T, XELOS DR-T ICD'S (P000009/S058)Biotronik, Inc.2014-11-17
DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR RIGHT ATRIAL PACEMAKER ELECTRODES, DEXTRUS, SETROX, TILDA, SAFIO (P950037/S143)Biotronik, Inc.2014-11-06
ENTOVIS, EVIA, ESTELLA, EFFECTA, ECURO, DEXTRUS, SETROX, SELOX, TILDA, P-KIT, SAFIO, SLX, CARDIOMESSENGER LLT KIT, ICS (P950037/S141)Biotronik, Inc.2014-10-21
EVIA HF-T, ENTOVIS HF-T, STRATOS LV, COROX OTW, CELERITY 2D,LV-KIT (P070008/S056)Biotronik, Inc.2014-10-21
ICS 3000/ RENAMIC PROGRAMMERS (P000009/S059)Biotronik, Inc.2014-10-21
LINOX SMART SD, VIGILA 1CR, VOLTA 1CR, LINOX SMART S DX, PROTEGO SD (P980023/S062)Biotronik, Inc.2014-10-21
LLESTO 7 VR-T, IFORIA 7 VR-T, LLESTO 5 VR-T, IFORIA 5 VR-T, LUMAX 740 VR-T, LLESTO 7 DR-T, IFORIA 7 DR-T, LLESTO 5 DR-T (P050023/S080)Biotronik, Inc.2014-10-21
LINOX SMART SD, LINOX SMART TD, LINOX SMART S, LINOX SMART T, LINOX SMART S DX, VIGILA 1CR, VOLTA 1CR, KAINOX VCS,PROTEG (P980023/S061)Biotronik, Inc.2014-10-10
COROX OTW, COROX OTW-L, CELERITY (P070008/S055)Biotronik, Inc.2014-10-10
SELOX ST, SELOX JT, SETROX S, DEXTRUS, TILDA, SOLOX SLX, SAFIO (P950037/S140)Biotronik, Inc.2014-10-10
ILESTO/IFORIA 5 & 7 ICD/CRT-D FAMILIES (P050023/S078)Biotronik, Inc.2014-10-10
VOLTA(1CR/2CR/CT/2CT) ICD LEAD, PROTEGO (S/SD/T/TD) ICD LEAD,KAINOX VCS 60 ICD LEADLINOX SMART (S/SD/T/TD/S DX) ICD LEAD (P980023/S060)Biotronik, Inc.2014-09-16
CELERITY 2D/3D/PILOT STEROID-ELUTING LV LEAD, COROX (-S/-L) BP STEROID-ELUTING LV LEAD (P070008/S054)Biotronik, Inc.2014-09-16
DEXTRUS, SELOX ST/JT, SETROX S, AND TILDA T/JT/R STEROID-ELUTING PACING LEADS; SOLOX SLX -BP PACING LEAD (P950037/S138)Biotronik, Inc.2014-09-16
REOCOR S/D EXTERNAL PACEMAKER (P950037/S135)Biotronik, Inc.2014-07-16
SELOX, TILDA, SOLOX (P950037/S136)Biotronik, Inc.2014-07-11
COROX, CELERITY (P070008/S052)Biotronik, Inc.2014-07-11
LINOX SMART SD, VIGILA, VOLTA (P980023/S059)Biotronik, Inc.2014-07-11
PROTEGO FAMILY OF ICD LEADS (P980023/S057)Biotronik, Inc.2014-07-03
ILESTO/IFORIA 5/7 VRT/DRT ICD'S, ILESTO/IFORIA 5/7 HF-T CRT-D (P050023/S076)Biotronik, Inc.2014-07-03
VARIOUS MODELS OF SLX LEADS AND VARIOUS MODELS OF SELOX,DEXTRUS,AND SAFIO DRUG ELUTING LEADS (P950037/S134)Biotronik, Inc.2014-06-30
VARIOUS MODELS OF COROX, CELERITY AND LV LEADS (P070008/S051)Biotronik, Inc.2014-06-30
KAINOX VCS,DF1-C6HV,AND VARIOUS MODELS OF LINOX,EFH, AND PROTEGO LEADS (P980023/S058)Biotronik, Inc.2014-06-30
LUMAX FAMILIES OF ICD'S & CRT-D'S, ILESTO & IFORNIA FAMILIES OF ICD'S & CRT-D'S (P050023/S072)Biotronik, Inc.2014-06-20
LUMOS FAMILY OF ICD'S (P000009/S056)Biotronik, Inc.2014-06-20
STRATOS, EVIA, & ENTOVIS FAMILIES OF CRT-P'S (P070008/S049)Biotronik, Inc.2014-06-20
CYLOS, PHILOS/PHILOS II, EVIA, ENTOVIA, ECURO, EFFECTA, & ESTELLA FAMILIES OF PACEMAKERS (P950037/S131)Biotronik, Inc.2014-06-20
XELOS DR-T ICD'S (P000009/S057)Biotronik, Inc.2014-05-04
ENTOVIS PROMRI PACEMAKER SYSTEM (P950037/S132)Biotronik, Inc.2014-05-04
ILESTO ICD'S AND CRT-D'S (P050023/S074)Biotronik, Inc.2014-05-04
EVIA CRT-P'S (P070008/S050)Biotronik, Inc.2014-05-04
LUMAX 6/7 AND ILESTO/IFORIA ICD/CRT D FAMILIES (P050023/S075)Biotronik, Inc.2014-03-11
LUMAX 3XO/5X10 (P050023/S073)Biotronik, Inc.2014-01-17
LINOX (P980023/S054)Biotronik, Inc.2014-01-17
SELOX ST 53,SELOX ST 60,SELOX JT 45,SELOX JT 53,SETROX S 45,SETROX S53,SETROX S60,DEXTRUS 4135,DEXTRUS 4136,DETRUS 4137, (P950037/S133)Biotronik, Inc.2014-01-06
STRATOS LV AND LV-T CRT-P'S (P070008/S048)Biotronik, Inc.2013-12-03
LUMAX FAMILIES OF ICD'S (P050023/S070)Biotronik, Inc.2013-12-03
LUMAX FAMILIES OF ICD'S & CRT-D'S (P050023/S071)Biotronik, Inc.2013-12-03
EVIA FAMILY OF PACEMAKERS (P950037/S130)Biotronik, Inc.2013-12-03
EVIA FAMILY OF PACEMAKERS (P950037/S129)Biotronik, Inc.2013-12-03
CYLOS , PHILOS, PHILOS II, EVIA, ENTOVIS, EURO EFFECTA, ESTELLA FAMILY (P950037/S128)Biotronik, Inc.2013-09-26
LUMAX 300/340; 500/540; 540 VR-T DX; 600/640;700/740 FAMILY, IFORIA 7/5 FAMILY; ILESTO 7/5/FAMILY (P050023/S069)Biotronik, Inc.2013-09-26
LUMAS FAMILY (P000009/S055)Biotronik, Inc.2013-09-26
STRATOS FAMILY, EVIA FAMILY, ENTOVIS FAMILY (P070008/S047)Biotronik, Inc.2013-09-26
ENTOVIS HF (-T),EVIA HF(-T) (P070008/S046)Biotronik, Inc.2013-09-26
ECURO,EFFECTA,ESTELLA,EVIA,ENTOVIS (P950037/S127)Biotronik, Inc.2013-09-26
IFORIA VR-T ICD, LLESTO VR-T ICD, LUMAX VR-T ICD,IFORIA VR-T DX ICD, LLESTO VR-T DX ICD, LUMAX VR-T DX ICD, (P050023/S068)Biotronik, Inc.2013-08-14
ECURO, EFFECTA, ESTELLA,EVIA, ENTOVIS IMPLANTABLE PACEMAKER (P950037/S126)Biotronik, Inc.2013-08-14
ENTOVIS HF(-T) CRT-P, EVIA HF(-T) CRT-P, STRATOS CRT-P (P070008/S045)Biotronik, Inc.2013-08-14
LINOX S DX (P980023/S056)Biotronik, Inc.2013-07-30
ECURO, EFFECTA, ESTELLA, EVIA ENTOVIS (P950037/S125)Biotronik, Inc.2013-07-30
LLESTO, IFORIA, LUMAX, (P050023/S067)Biotronik, Inc.2013-07-30
LUMAX (P050023/S066)Biotronik, Inc.2013-07-30
ENTOVIS HF(-T), EVIA HF (-T) (P070008/S044)Biotronik, Inc.2013-07-30
RENAMIC (P950037/S124)Biotronik, Inc.2013-07-12
KAINOX VCS,LINOX,LINOX SMART,VIGILA,VOLTA (P980023/S055)Biotronik, Inc.2013-05-29
DEXTRUS,ECURO,EFFECTA,ESTELLA,EVIA,ENTOVIS,SELOX,SETROX S,SOLOX,TILDA (P950037/S123)Biotronik, Inc.2013-05-29
CELERITY,COROX,ENTOVIS HF(-T),EVIA HF (-T),STRATOS (P070008/S043)Biotronik, Inc.2013-05-29
ILESTO,IFORIA,LUMAX (P050023/S065)Biotronik, Inc.2013-05-29
CELERITY,COROX (P070008/S042)Biotronik, Inc.2013-05-17
COROX OTW 75 UP STEROID,COROX OTW 85 UP STEROID (P050023/S064)Biotronik, Inc.2013-05-17
KAINOX VCS,LINOX,LINOX SMART,VIGILA,VOLTA (P980023/S053)Biotronik, Inc.2013-05-17
DEXTRUS,SELOX,SETROX S,SOLOX,TILDA (P950037/S122)Biotronik, Inc.2013-05-17
BELOS VR-T (P980023/S052)Biotronik, Inc.2013-05-08
PHILOS DR-T,PHILOS II DR-T,CYLOS DR-T,EVIA DR-T/EVIA SR-T,ENTOVIS DR-T/ENTOVIS SR-T,ESTELLA DR-T/ESTELLA SR-T (P950037/S121)Biotronik, Inc.2013-05-08
BELOS DR-T,BELOS A+-T,LEXOS DR-T/LEXOS VR-T,XELOS DR-T,LUMOS DR-T/LUMOS VR-T (P000009/S054)Biotronik, Inc.2013-05-08
LUMAX 300 DR-T/LUMAX 340 DR-T,LUMAX 300 VR-T/LUMAX 340 VR-T,LUMAX 500 DR-T/LUMAX 540 DR-T,LUMAX 500 VR-T/LUMAX 540 VR-T, (P050023/S063)Biotronik, Inc.2013-05-08
STRATOS LV-T,EVIA HF-T (P070008/S041)Biotronik, Inc.2013-05-08
STRATOS (P070008/S039)Biotronik, Inc.2013-03-25
ECURO, EFFECTA, ENTOVIS, ESTELLA, EVIA (P950037/S119)Biotronik, Inc.2013-03-25
LUMAX (P050023/S061)Biotronik, Inc.2013-03-25
VARIOUS MODELS OF IPG'S: ACTROS, AXIOS, CYLOS, DROMOS, KAIROS, PHILOS/II, PROTOS, ETC. (P950037/S116)Biotronik, Inc.2013-03-18
BELOS & LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S (P000009/S051)Biotronik, Inc.2013-03-18
STRATOS LV/LV-T, EVIA AND ENTOVIS HF/HF-T CRT-P'S (P070008/S036)Biotronik, Inc.2013-03-18
ILESTO 7/ 5 VR-T ICD, IFORIA 7/ 5 VR-T ICD, ILESTO 7/ 5 VR-T DX ICD, ILFORIA 7/ 5 VR-T DX ICD, ILESTO 7/ 5 DR-T ICD (P050023/S058)Biotronik, Inc.2013-03-18
COROX OTW 85 UP STEROID, LUMAX 300 DR-T, LUMAX 340 DR-T,LUMAX 300 VR-T, LUMAX 340 VR-T, LUMAX 500 DR-T,LUMAX 540 DR-T, L (P050023/S060)Biotronik, Inc.2013-02-19
KAINOX VCS,SLX 58/11-BP,SLX 58/13-BP,SLX 58/14-BP,SLX 58/15-BP,SLX 58/17-BP,LINOX S 65,LINOX S 75, LINOX T 65,LINOX T75, (P980023/S051)Biotronik, Inc.2013-02-19
STRATOS LV,EVIA HF,EVIA HF-T,ENTOVIS HF,ENTOVIS HF-T,COROX OTW 85 UP STEROID,COROX OTW 75-BP,COROX OTW 85-BP,COROX OTW-S (P070008/S038)Biotronik, Inc.2013-02-19
EVIA DR, EVIA DR-T,EVIA SR, EVIA SR-T,ENTOVIS DR, ENTOVIS DR-T,ENTOVIS SR,ENTOVIS SR-T,ESTELLA SR,ESTELLA SR-T,ECURO DR, (P950037/S118)Biotronik, Inc.2013-02-19
LINOX(SMART) S DX STEROID-ELUTING SINGLE-COIL ICD LEADS (P980023/S049)Biotronik, Inc.2013-02-13
EVIA HF,EVIA HF-T, ENTOVIS HF, ENTOVIS HF-T (P070008/S035)Biotronik, Inc.2013-02-12
LUMAX FAMILY OF ICD AND CRT-D (P050023/S057)Biotronik, Inc.2013-02-12
EVIA/ENTOVIS/ECURO/EFFECTA/ESTELLA PULSE GENERATORS (P950037/S113)Biotronik, Inc.2013-02-12
PHILOS DR-T,PHILOS II DR-T, CYLOS DR-T, EVIA DR-T,EVIA SR-T, ENTOVIS DR-T,ENTOVIS SR-T (P950037/S117)Biotronik, Inc.2013-01-31
BELOS VR-T (P980023/S050)Biotronik, Inc.2013-01-31
BELOS VR-T, BELOS DR-T, BELOS A +-T, LEXOS DR-T,LEXOS VR-T,XELOS DR-T, LUMOS DR-T,LUMOS VR-T (P000009/S052)Biotronik, Inc.2013-01-31
STRATOS LV-T (P070008/S037)Biotronik, Inc.2013-01-31
LUMAX 300 DR-T,LUMAX 340 DR-T, LUMAX 300 VR-T, LUMAX 340 VR-T, LUMAX 500 DR-T, LUMAX 540 DR-T, LUMAX 500 VR-T, LUMAX 540 (P050023/S059)Biotronik, Inc.2013-01-31
COROX OTW 75-UP STEROID LEAD, COROS OTW 85-UP STEROID LEAD (P050023/S056)Biotronik, Inc.2013-01-11
EVIA DR, EVIA SR, ENTOVIS DR, ENTOVIS SR, ESTELLA DR, ESTELLA SR, EFFECTA D, EFFECTA DR, EFFECTA S, EFFECTA SR, ECURO DR (P950037/S114)Biotronik, Inc.2012-12-19
STRATOS LV & STRATOS LV-T (P070008/S032)Biotronik, Inc.2012-12-03
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