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Biotronik, Inc.

945 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
LUMAX FAMILY OF ICDS/CRT-DS (P050023/S001)Biotronik, Inc.2006-12-07
LUMAX IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P950037/S046)Biotronik, Inc.2006-12-07
LUMAX FAMILY OF ICDS/CRT-DS (P980023/S025)Biotronik, Inc.2006-12-07
TUPOS LV/ATX & KRONOS LV-T CRT-DS & COROX OTW STEROID LV PACING LEAD (P050023/S002)Biotronik, Inc.2006-10-30
TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD (P050023)Biotronik, Inc.2006-08-10
VARIOUS MODELS OF PACEMAKERS ICS 3000/ EPR 1000 PLUS (P950037/S045)Biotronik, Inc.2006-07-26
VARIOUS MODELS OF ICD'S (P000009/S019)Biotronik, Inc.2006-07-26
VARIOUS MODELS ICD'S TMS 1000 PLUS (P980023/S024)Biotronik, Inc.2006-07-26
LINOX TD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS (P980023/S023)Biotronik, Inc.2006-07-11
ACTROS, AXIOS, CYLOC, DROMOS, ERGOS, GEMNOS, KAIROS, KALOS, NANOS, NEOS, PHILOS, PHILOS II, PIKOS, PROTOS, TRIOS, BA03.. (P950037/S043)Biotronik, Inc.2006-04-24
CARDIAC AIRBAG (P980023/S021)Biotronik, Inc.2006-04-24
BELOS,LEXOS,LUMOS,XELOS DUAL CHAMBER ICD FAMILIES (P000009/S017)Biotronik, Inc.2006-04-24
SETROX S STEROID-ELUTING ACTIVE-FIXATION ENDOCARDIAL PACING LEAD (MODELS SETROX S 45, SETROX S 53, AND SETROX S 60) (P950037/S042)Biotronik, Inc.2006-02-14
LINOX SD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS (P980023/S020)Biotronik, Inc.2006-01-27
CYLOS FAMILY OF PULSE GENERATORS (P950037/S041)Biotronik, Inc.2005-12-21
LUMOS VR-T AND LUMOS DR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH 502.U ICS PROGRAMMER SOFTWARE, A-K00.4.U EPR/... (P000009/S016)Biotronik, Inc.2005-08-11
KENTROX FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS, RV, SL, RV-S, SLS (P980023/S019)Biotronik, Inc.2005-07-18
PROTOS DR/CLS AND PROTOS VR/CLS (P950037/S039)Biotronik, Inc.2005-06-22
BELOS, CARDIAC AIRBAG, LEXOS, AND XELOS FAMILIES OF ICDS (P000009/S015)Biotronik, Inc.2005-06-22
IMPLANT CONTROL SYSTEM (ICS) 3000 (P950037/S035)Biotronik, Inc.2005-05-18
XELOS DR-T ICD SYSTEM AND APPLICATION SOFTWARE VERSION A-K00.3.U (P000009/S014)Biotronik, Inc.2005-04-28
SELOX ST/JT STEROID-ELUTING PASSIVE-FIXATION ENDOCARDIAL PACKING LEAD MODELS SELOX ST 53, SELOX ST 60, SELOX JT 45 & 53 (P950037/S038)Biotronik, Inc.2004-11-10
KENTROX RV-S STEROID AND KENTROX SL-2 STEROID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS (P980023/S017)Biotronik, Inc.2004-09-30
PROGRAMMER SOFTWARE A-K00.2.U IN THE LEXOS, BELOS AND CARDIAC AIRBAG IMPLANTABLE CARDIOVERTER DEFIBRILLATS (P000009/S013)Biotronik, Inc.2004-09-17
KENTROX RV STEROID AND KENTROX SL STEROID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS (P980023/S018)Biotronik, Inc.2004-07-27
THE BELOS, TACHOS ATX, AND LEXOS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FAMILIES AND CARDIAC AIRBAG (P000009/S012)Biotronik, Inc.2004-06-22
TACHOS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS AND PROGRAMMER SOFTWARE VERSION A-K00.1.U/5 (P000009/S011)Biotronik, Inc.2004-04-22
PHILOS DR-T PULSE GENERATOR AND A-K00.1.U/5 PROGRAMMER SOFTWARE (P950037/S037)Biotronik, Inc.2004-03-31
PHILOS II DR, PHILOS II D, PHILOS II DR-T, PHILOS II SLR, PHILOS II SR, PHILOS II S, AND PROGRAMMER SOFTWARE VERSION A-U (P950037/S036)Biotronik, Inc.2004-03-31
PROTOS DR/CLS, PROTOS VR/CLS, AXIOS DR, AXIOS D, AXIOS S, AXIOS SR, AND AXIOS SLR PULSE GENERATORS WITH PROGRAMMER SOFT (P950037/S032)Biotronik, Inc.2004-03-31
BELOS A+ /BELOS A+/T, /KAINOX A+ 75/15, /KAINOX A+ 75/17 (P000009/S008)Biotronik, Inc.2004-03-19
KENTROX SL ICD LEADS (P980023/S016)Biotronik, Inc.2004-03-12
SELOX SR STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEAD MODELS SR45, SR53, SR60 SR 53,SELOX SR 60 (P950037/S034)Biotronik, Inc.2004-03-08
PHILOS DR-T PULSE GENERATOR/ICD BELOS VR-T,DR-T,ICD CARDIAC AIRBAG-T (P950037/S033)Biotronik, Inc.2003-12-17
KENTROX RV-S/KENTROX SL-S ICD LEADS (P980023/S012)Biotronik, Inc.2003-11-18
BELOS A+ AND BELOS A+/T ICD AND KAINOX A+ ICD LEAD (SINGLE-LEAD SYSTEM) (P000009/S009)Biotronik, Inc.2003-11-13
CARDIAC AIRBAG ICD, 345-424, CARDIAC AIRBAG-T ICD, 341-517, A-K00.1.U. PROGRAMMER SOFTWARE, 346-168 (P980023/S015)Biotronik, Inc.2003-10-31
BELOS AND CARDIAC AIRBAG FAMILIES (P000009/S010)Biotronik, Inc.2003-10-14
PHILOS DR ACC PACING SYSTEM AND PROGRAMMER SOFTWARE VERSION B-KAC.V.U/1 (P950037/S030)Biotronik, Inc.2003-08-04
KENTROX RV 65, KENTROX RV 75, KAINOX SL 65/13, KAINOX SL 65/18 (P980023/S013)Biotronik, Inc.2003-07-29
TACHOS ATX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND PROGRAMMER SOFTWARE (P000009/S007)Biotronik, Inc.2003-05-29
CARDIAC AIRBAG / CARDIAC AIRBAG-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980023/S014)Biotronik, Inc.2003-05-14
SOLOX VDD PACING LEAD (P950037/S024)Biotronik, Inc.2003-04-23
CARDIOMESSENGER HOME MONITORING SYSTEM (P950037/S031)Biotronik, Inc.2003-02-25
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P000009/S006)Biotronik, Inc.2002-12-20
PROTOS FAMILY OF PULSE GENERATORS (P950037/S029)Biotronik, Inc.2002-12-20
PERMANENT PACEMAKER ELECTRODE (P820076/S023)Biotronik, Inc.2002-12-20
IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD'S) (P980023/S011)Biotronik, Inc.2002-12-20
BELOS DR AND BELOS DR-T DUAL-CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS (P000009/S005)Biotronik, Inc.2002-12-20
PROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE (P950037/S028)Biotronik, Inc.2002-12-06
KAINOX RV-S/ KAINOX VCS ICD LEADS (P980023/S009)Biotronik, Inc.2002-11-25
TACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD SYSTEM (P000009/S004)Biotronik, Inc.2002-09-09
ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U) (P980023/S010)Biotronik, Inc.2002-08-30
BELOS VR-T ICD (P980023/S008)Biotronik, Inc.2002-04-24
PHILOS DR-T PULSE GENERATOR (P950037/S023)Biotronik, Inc.2002-04-02
TACHOS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P000009/S003)Biotronik, Inc.2002-03-11
BELOS VR ICD SYSTEM (P980023/S006)Biotronik, Inc.2002-03-11
KENTROX RV LEAD SYSTEMS (P980023/S007)Biotronik, Inc.2002-02-21
AXIOS PULSE GENERATOR FAMILY/B-K05.S.U PROGRAMMER SOFTWARE (P950037/S022)Biotronik, Inc.2001-10-26
TEROX RV /KAINOX SL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR/LEAD MODELS (P980023/S005)Biotronik, Inc.2001-10-24
HOME MONITORING SYSTEM (P950037/S019)Biotronik, Inc.2001-10-11
BIOTRONIK INOS2+ CLS PULSE GENERATOR AND B-K05.V.U PROGRAMMER SOFTWARE (P950037/S020)Biotronik, Inc.2001-10-10
EDP 30 EXTERNAL DUAL CHAMBER PACEMAKER (P950037/S021)Biotronik, Inc.2001-09-10
TACHOS DR IMPLANTALBLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM (P000009/S002)Biotronik, Inc.2001-09-04
BELOS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P980023/S004)Biotronik, Inc.2001-07-12
ACTROS AND KAIROS FAMILY OF PULSE GENERATORS WITH LITRONIK BATTERY (P950037/S017)Biotronik, Inc.2001-05-24
TACHOS DR, TACHOS DR- ATRIAL TX,TACHOS ATX (P000009/S001)Biotronik, Inc.2001-03-05
PHILOS PACING SYSTEM (P950037/S018)Biotronik, Inc.2001-02-05
PHILOS FAMILY OF PULSE GENERATORS (P950037/S016)Biotronik, Inc.2000-10-31
ACTROS SLR PULSE GENERATOR (P950037/S013)Biotronik, Inc.2000-10-13
PHYLAX AV ICD SYSTEM (P000009)Biotronik, Inc.2000-09-29
PHILOS PULSE GENERATORS AND ASSOCIATED PROGRAMMER SOFTWARE. (P950037/S015)Biotronik, Inc.2000-09-05
PHILOS PULSE GENERATOR (P950037/S011)Biotronik, Inc.2000-06-28
PHILOS PULSE GENERATOR FAMILY AND SWM1000 B-K-00.0U SOFTWARE CARTRIDGE (P950037/S012)Biotronik, Inc.2000-06-22
ACTROS FAMILY OF PULSE GENERATORS (P950037/S014)Biotronik, Inc.2000-06-20
PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P980023/S003)Biotronik, Inc.2000-05-01
PHYLAX 06 ICD/ACTIVE HOUSING/REPLACEMENT, MYCROPHYLAX/TMS 1000 TACHYARRHYTHMIA MONITORING SYSTEM (P980023/S002)Biotronik, Inc.1999-09-13
ACTROS+ FAMILY OF PULSE GENERATORS (P950037/S008)Biotronik, Inc.1999-08-24
GEMNOS & DROMOS SL PULSE GENERATORS (P820076/S022)Biotronik, Inc.1999-08-24
ACTROS SLR+,KAIROS SL PULSE GENERATORS;SL 60-11,13,15 BP SINGLE PASS PACING LEAD;SWM 1000 B-G01.0.U (P950037/S007)Biotronik, Inc.1999-08-04
ACTROS DR+ -B PULSE GENERATOR (P950037/S009)Biotronik, Inc.1999-06-07
PHYLAX ICD (P980023/S001)Biotronik, Inc.1999-04-19
ACTROS+ (P950037/S006)Biotronik, Inc.1999-01-05
KAIROS (P950037/S005)Biotronik, Inc.1998-11-19
DROMOS S.L. PACING SYSTEM (P820076/S021)Biotronik, Inc.1998-11-04
PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P980023)Biotronik, Inc.1998-10-27
ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM (P950037/S004)Biotronik, Inc.1998-09-24
ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM (P950037/S003)Biotronik, Inc.1998-08-13
DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S002)Biotronik, Inc.1998-08-13
DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S001)Biotronik, Inc.1998-03-13
BIOTRONIK GEMNOS 04 AND GEMNOS TC O4 (P820076/S018)Biotronik, Inc.1996-11-21
DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037)Biotronik, Inc.1996-10-11
MODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U (P820076/S019)Biotronik, Inc.1996-01-24
BIOTRONIK GEMNOS 04, 04A, AND TC 04 (P820076/S020)Biotronik, Inc.1995-12-22
BIOTRONIK SOFTWARE MODULE SWM 600 V.D05U01 (P820076/S017)Biotronik, Inc.1995-09-07
GEMNOS TC 04 PULSE GENERATOR & SOFTWARE MODULE (P820076/S016)Biotronik, Inc.1994-09-19
GEMNOS(TM)04A CARDIAC PACEMAKER & SWM 600/C00U02 (P820076/S015)Biotronik, Inc.1993-12-08
GEMNOS(TM) 04 CARDIAC PACEMAKER & SWN 600/C00U02 (P820076/S014)Biotronik, Inc.1993-02-09
PMS-600 PROGRAMMER (P820076/S013)Biotronik, Inc.1992-02-07
GEMNOS (TM) CARDIAC PACEMAKER (4.34) (P820076/S011)Biotronik, Inc.1991-12-20
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