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Biotronik, Inc.

945 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
EVIA / ENTOVIS & VARIOUS OTHER PULSE GENERATORS (P950037/S072)Biotronik, Inc.2010-05-07
EVIA/ENTOVIS PULSE GENERATORS (P000009/S035)Biotronik, Inc.2010-05-07
LUMAX 540 VR-T DX ICD (P050023/S029)Biotronik, Inc.2010-04-30
LUMAX 540 VR-T DX ICDS (P950037/S078)Biotronik, Inc.2010-04-30
SETROX S & DEXTRUS LEADS (P950037/S077)Biotronik, Inc.2010-03-12
LINOX SD & LINOX S (P980023/S039)Biotronik, Inc.2010-03-12
LUMAX FAMILIES OF ICDS & CRT-DS (P050023/S027)Biotronik, Inc.2010-03-05
STRATOS LV/LV-T (P070008/S014)Biotronik, Inc.2010-01-22
ACTROS, AXIOS, KAIROS, CYLOS, DROMOS, PHILOS, AND PHILOS II FAMILIES OF PACEMAKER PULSE GENERATORS AND PROGRAMMERS (P950037/S074)Biotronik, Inc.2010-01-22
BELOS & LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T/XELOS DR-T (P000009/S038)Biotronik, Inc.2010-01-22
LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T (P050023/S028)Biotronik, Inc.2010-01-22
ACTROS & AXIOS & KAIROS DR/SR/SLR/D/S/BA03 DDDR/CYLOS DR/DR-T/VR/DOMOS DR/SR/SL/PHILOS&PHILOS II DR/DR-T/SR/SLR/D/S/PROT (P950037/S076)Biotronik, Inc.2010-01-22
LEAD FIXATION SLEEVE (P070008/S013)Biotronik, Inc.2009-10-28
HOME MONITORING SERVICE CENTER 3 - VERSION 3.6 (P070008/S012)Biotronik, Inc.2009-10-22
HOME MONITORING SERVICE CENTER 3 - VERSION 3.6 (P050023/S026)Biotronik, Inc.2009-10-22
HOME MONITORING SERVICE CENTER 3 - VERSION 3.6 (P950037/S073)Biotronik, Inc.2009-10-22
HOME MONITORING SERVICE CENTER 3 - VERSION 3.6 (P000009/S036)Biotronik, Inc.2009-10-22
LUMAX FAMILY OF ICDS (P050023/S020)Biotronik, Inc.2009-05-12
LUMOS DR-T AND LUMOS VR-T (P000009/S033)Biotronik, Inc.2009-05-12
PHILOS II DR-T (P950037/S068)Biotronik, Inc.2009-05-12
STRATOS LV-T (P070008/S009)Biotronik, Inc.2009-05-12
PULSE GENERATORS PHILOS II DR-T/CYLOS DR-T (P950037/S071)Biotronik, Inc.2009-04-16
CARDIOMESSENGER II-S (TLINE) SOFTWARE VERSION 1.20, CARDIOMESSENGER LLT, CARDIOMESSENGER TLINE; CARDIOMESSENGER II (P050023/S023)Biotronik, Inc.2009-04-16
ICS 3000/EDP 30/CARDIOMESSENGER (P950037/S070)Biotronik, Inc.2009-04-03
CARDIOMESSENGER TLINE/CARDIOMESSENGER II/CARDIOMESSENGER II-S (P050023/S022)Biotronik, Inc.2009-04-03
PROGRAMMER SOFTWARE (ICS 3000 802.U/2) (P950037/S067)Biotronik, Inc.2009-03-31
PROGRAMMER SOFTWARE (ICS 3000 802.U/2) (P000009/S032)Biotronik, Inc.2009-03-31
PROGRAMMER SOFTWARE (ICS 3000 802.U/2) (P980023/S036)Biotronik, Inc.2009-03-31
STRATOS LV AND LV-T PULSE GENERATORS (P070008/S008)Biotronik, Inc.2009-03-31
LUMAX FAMILY OF ICDS (P050023/S019)Biotronik, Inc.2009-03-31
BELOS VR-T, DR-T & A+-T; LEXOS DR-T & VR-T; XELOS DR-T; LUMOS DR-T & VR-T (P000009/S034)Biotronik, Inc.2009-03-23
LUMAX FAMILY OF ICDS AND KRONOS LV-T (P050023/S021)Biotronik, Inc.2009-03-23
STRATOS LV-T (P070008/S010)Biotronik, Inc.2009-03-23
PHILOS DR-T, PHILOSII DR-T AND CYLOS DR-T (P950037/S069)Biotronik, Inc.2009-03-23
LEXOS & LUMOS FAMILIES OF ICDS (P000009/S030)Biotronik, Inc.2009-03-12
LUMAX FAMILIES OF ICDS (P050023/S017)Biotronik, Inc.2009-03-12
LINOX SD 60/16 STEROID-ELUTING, ACTIVE FIXATION ICD LEAD (P980023/S037)Biotronik, Inc.2009-01-05
CYLOS/PROTOS/AXIOS/PHILOS II & PHILOS/PHILOS DR-T PULSE GENERATORS (P950037/S063)Biotronik, Inc.2008-12-31
STRATOS LV (T) PULSE GENERATOR (P070008/S006)Biotronik, Inc.2008-12-31
LUMOS & TACHOS & BELOS FAMILY OF ICDS & XELOS DR-T (P000009/S029)Biotronik, Inc.2008-12-24
TUPOS LV/ATX, KRONOS LV-T, LUMAX 300/340 FAMILY OF ICDS AND CRT-DS (P050023/S015)Biotronik, Inc.2008-12-24
CARDIOMESSENGER II-S AND CARDIOMESSENGER II-S TLINE HOME MONITORING DEVICES (P050023/S016)Biotronik, Inc.2008-12-11
CYLOS DR-T PULSE GENERATOR (P950037/S064)Biotronik, Inc.2008-11-24
CARDIAC AIRBAG-T AND BELOS VR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980023/S035)Biotronik, Inc.2008-11-21
LUMAX FAMILY OF ICDS (P050023/S018)Biotronik, Inc.2008-11-21
STRATOS LV-T PULSE GENERATOR (P070008/S007)Biotronik, Inc.2008-11-21
PHILOS II FAMILY OF PULSE GENERATORS (P950037/S066)Biotronik, Inc.2008-11-21
LEXOS & LUMOS FAMILIES OF ICDS (P000009/S031)Biotronik, Inc.2008-11-21
PHILOS II FAMILY OF PULSE GENERATORS (P950037/S065)Biotronik, Inc.2008-11-06
COROX OTW (-S) BP LEFT VENTRICULAR LEADS (P070008/S005)Biotronik, Inc.2008-11-06
LUMOS ICDS/XELOS DR-T ICD/LEXOS ICDS (P000009/S026)Biotronik, Inc.2008-11-04
KRONOS LV-T CRT-D (P050023/S011)Biotronik, Inc.2008-11-04
ACTROS, AXIOS, BA03, CYLOS, DROMOS, KAIROS, PHILOS, PHILOS II, AND PROTOS FAMILIES OF PULSE GENERATORS (P950037/S059)Biotronik, Inc.2008-11-04
CARDIAC AIRBAG AND BELOS FAMILIES OF ICDS (P980023/S031)Biotronik, Inc.2008-11-04
STRATOS LV/LV-T (P070008/S001)Biotronik, Inc.2008-11-04
VARIOUS MODELS OF PHILOS/PHILOS, AXIOS, PROTOS PULSE GENERATOR (P950037/S057)Biotronik, Inc.2008-07-11
STRATOS LV-T (P070008/S003)Biotronik, Inc.2008-06-24
PHYLAX IMPLANTABLE CARDIOVERTER DIFIBRILLATOR (P980023/S033)Biotronik, Inc.2008-06-09
DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC (P950037/S061)Biotronik, Inc.2008-06-09
PHYLAX AV ICD SYSTEM (P000009/S028)Biotronik, Inc.2008-06-09
KRONOS LV-T CRT-D (P050023/S013)Biotronik, Inc.2008-06-09
PHYLAX AV ICD SYSTEM (P000009/S027)Biotronik, Inc.2008-06-02
PHYLAX IMPLANTABLE CARDIOVERTER DIFIBRILLATOR SYSTEM (P980023/S032)Biotronik, Inc.2008-06-02
DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEM (P950037/S060)Biotronik, Inc.2008-06-02
STRATOS LV & STRATOS LV-T-CRT-P'S (P820076/S024)Biotronik, Inc.2008-06-02
KRONOS LV-T CRT-D (P050023/S012)Biotronik, Inc.2008-06-02
STRATOS LV/LV-T (P070008/S002)Biotronik, Inc.2008-06-02
STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD (P070008)Biotronik, Inc.2008-05-12
CYLOS DR, PROTOS DR-CLS, PHILOS 2 DR, PHILOS DR, AXIOS DR (P950037/S058)Biotronik, Inc.2008-04-11
LEXOS AND LUMOS ICDS & XELOS DR-T ICD (P000009/S024)Biotronik, Inc.2008-03-11
LUMAX ICDS & CRT-DS (P050023/S008)Biotronik, Inc.2008-03-11
LUMOS VR/DR (-T) AND LEXOS DR/VR (-T) ICD'S (P000009/S025)Biotronik, Inc.2008-03-10
LUMAX VR/DR/HF (-T) ICD'S & CRT-D'S (P050023/S009)Biotronik, Inc.2008-03-10
LINOX SD, TD & S/T (P980023/S030)Biotronik, Inc.2008-02-29
SELOX ST/JT, SETROX S & DEXTRUS (P950037/S056)Biotronik, Inc.2008-02-29
LUMAX FAMILY OF ICDS AND CRT-DS (P050023/S010)Biotronik, Inc.2008-02-08
KRONOS LV-T CRT-D & LUMAX VR/DR/HF (-T) ICDS & CDT-DS (P050023/S006)Biotronik, Inc.2007-12-07
LEXOS DR/VR(-T) ICDS & LUMOS VR/DR (-T) & XELOS DR-T ICD & BELOS DR (-T) ICDS (P000009/S022)Biotronik, Inc.2007-12-07
ICS 3000 IMPLANT CONTROL SYSTEM (P950037/S055)Biotronik, Inc.2007-12-07
CARDIAC AIRBAG (-T) ICDS & BELOS VR (-T) ICDS & TMS 1000 PLUS PROGRAMMING SYSTEM (P980023/S029)Biotronik, Inc.2007-12-07
CYLOS PACEMAKER & PHILOS II PACEMAKERS & ICS 3000 IMPLANT CONTROL SYSTEM & IMPLANT MODULE (P950037/S053)Biotronik, Inc.2007-12-07
CARDIOMESSENGER II (P950037/S054)Biotronik, Inc.2007-11-09
CARDIOMESSENGER TLINE (P000009/S023)Biotronik, Inc.2007-11-09
CARDIOMESSENGER (CM LLT, CM T LINE AND CM II) (P050023/S007)Biotronik, Inc.2007-11-09
PHILOS AND AXIOS FAMILY OF PULSE GENERATORS (P950037/S051)Biotronik, Inc.2007-08-31
PHILOS FAMILY OF PULSE GENERATORS (P950037/S052)Biotronik, Inc.2007-07-25
LINOX S AND LINOX T ICD LEADS (P980023/S028)Biotronik, Inc.2007-07-25
LUMAX FAMILY OF CRT-DS (P050023/S005)Biotronik, Inc.2007-07-25
VARIOUS MODELS OF PHILOS/AXIOS/PROTOS/CYLOS PG'S (P950037/S049)Biotronik, Inc.2007-03-26
DEXTRUS STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEADS MODELS 4135,4136 & 4137 (P950037/S048)Biotronik, Inc.2007-03-08
BIOTRONIK PACING AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P950037/S044)Biotronik, Inc.2007-02-15
BIOTRONIK PACING AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980023/S022)Biotronik, Inc.2007-02-15
KAINOX A+ ICD LEAD (P000009/S018)Biotronik, Inc.2007-02-15
LUMAX CRT DEVICE & CARDIOMESSENGER II (P050023/S003)Biotronik, Inc.2007-02-13
PHILOS DR-T AND CYLOS DR-T (P950037/S050)Biotronik, Inc.2007-02-13
SELECTED MODELS OF DUAL CHAMBER ICD DEVICES (P000009/S021)Biotronik, Inc.2007-01-30
SELECTED MODELS OF IPG BRADY CARDIA DEVICES (P950037/S047)Biotronik, Inc.2007-01-30
SELECTED MODELS OF SINGLE CHAMBER ICD DEVICES (P980023/S026)Biotronik, Inc.2007-01-30
LINOX S & LINOX T IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS (P980023/S027)Biotronik, Inc.2007-01-26
LUMAX FAMILY OF ICDS/CRT-DS (P000009/S020)Biotronik, Inc.2006-12-07
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