FDA.reportPublic FDA data

BIOTRONIK, INC.

Matched from indexed company URL: Biotronik, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10282321028232BIOTRONIK, INC.1Y2026-01-016024 JEAN RD. LAKE OSWEGO OR US 97035
80438923002808050BIOTRONIK AG1N2026-01-01ACKERSTRASSE 6 BULACH Zurich CH CH-8180
30270631903027063190BIOTRONIK NRO, INC.1Y2026-01-016024 Jean Road Lake Oswego OR US 97035

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07640130433779Passeo-14 - 3.5/140/150612-423-1738FDA.US.Agent@teleflex.com
07640130433786Passeo-14 - 4/140/150612-423-1738FDA.US.Agent@teleflex.com
07640130433809Passeo-14 - 2/180/150612-423-1738FDA.US.Agent@teleflex.com
07640130433816Passeo-14 - 2.5/180/150612-423-1738FDA.US.Agent@teleflex.com
07640130433823Passeo-14 - 3/180/150612-423-1738FDA.US.Agent@teleflex.com
07640130433861Passeo-14 - 2/220/150612-423-1738FDA.US.Agent@teleflex.com
07640130433878Passeo-14 - 2.5/220/150612-423-1738FDA.US.Agent@teleflex.com
07640130433885Passeo-14 - 3/220/150612-423-1738FDA.US.Agent@teleflex.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
281911713920620P980023PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMLWS1998-10-27
281911309454949P950037DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMSDXY1996-10-11
281911723237467P820076DIPLOS MODEL 05 A & BLWP1984-02-15
3161962054914776P210037Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote ManagementLGW2023-03-31
281911234382442P170030ORSIRO Sirolimus Eluting Coronary Stent SystemNIQ2019-02-22
839351263247262P170030ORSIRO Sirolimus Eluting Coronary Stent SystemNIQ2019-02-22
839351895965527P160025ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEMNIP2017-03-23
839351632727540P160003PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEMMAF2017-02-14
839351793172198P140030ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEMNIO2015-12-17
281911183288798P070008STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEADNKE2008-05-12
281911754526466P050023TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEADMRM2006-08-10
281911874963309P000009PHYLAX AV ICD SYSTEMMRM2000-09-29
281911843737205K982272GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018DQX1999-01-08
281911413560754K971930BK-N SEALING CAPDTD1997-08-14
281911436236894K970204BK-A; BK-B; BK-IS SEALING CAPDTD1997-04-29
281911853114577K964190ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZERDTE1997-07-10
839351284326705K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterLIT2025-04-04
281911998574796K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterLIT2025-04-04
281911336713106K240787Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)DQY2024-09-12
281911437751083K230375BIOMONITOR IVMXD2023-05-19
281911382647764K222037Selectra Lead Implantation SystemDQY2022-07-19
281911775582339K221856BIOMONITOR IIIm, BIOMONITOR IIIMXD2022-07-27
281912015623492K212593ViaCath, AcQRate Dx Steerable CatheterDRF2021-10-15
281911478818398K201445MultiCath, AcQRate Dx Fixed Curve CatheterDRF2021-09-02
281911816737245K200444Biomonitor III, Biomonitor IIImMXD2020-04-23
281911985179832K193474Selectra 3D Outer Guiding CathetersDQY2020-10-16
281911254174487K192996Selectra Catheters, Selectra Accessory Kit, Selectra Slitter ToolDQY2019-11-21
281911095329053K191469Biotronik StyletsDRB2019-08-01
281912027468016K190548BIOMONITOR III, Remote Assistant IIIMXD2019-07-05
281911310742017K183265Selectra Catheters, Selectra Accessory KitDQY2018-12-13
839351657566336K163660Pantera LEOLOX2017-01-26
839351056585236K160985Pantera ProLOX2016-10-07
839351855338479K153197Fortress Introducer Sheath SYstemDYB2016-01-11
281911108246177K152995BioMonitor 2-AF, BioMonitor 2-SMXD2016-04-11
839351927430492K152240Passeo-14 Peripheral Dilatation CatheterLIT2015-10-08
281911632616329K151409Selectra Catheters and Selectra Accessory KitDQY2015-08-07
281911092479465K143503BioMonitorMXD2015-03-19
839351236732730K142379Passeo-35 PTA CatheterLIT2014-12-05
839351856160047K130146SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEMNDN2013-05-20
281911248168846K113468ELM PTA BALLON DILATATION CATHETERLIT2011-12-20
839352044718311K113468ELM PTA BALLON DILATATION CATHETERLIT2011-12-20
839351802528173K102211CRUISER 18 GUIDEWIREDQX2010-09-03
839351828161358K100799FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815DYB2011-02-25
839351961452980K090193CONDUCTOR CORONARY GUIDEWIREDQX2009-09-25
281911467190724K083674PK-141 PATIENT CABLEDTC2009-04-01
281911277664842K083094STREAMER POLYMER GUIDEWIREDQX2009-07-07
281911084472692K082935VISION WIRE CORONARY GUIDEWIREDQX2008-12-04
839352072213833K082933PASSEO-35 PTA CATHETERDQY2008-11-03
839351317498973K072765PASSEO 18LIT2007-12-12
281911880553209K003454A1-CS-SB Y-ADAPTER, MODEL 124 871DTD2001-01-18
281911508469563K001736GALEO HYDRO AND GALEO HYDRO J-TIPDQX2000-08-02
839351038367706H170004
281911389265553H170004

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LIT82025-04-04
DQY72024-09-12
MXD62023-05-19
DQX62010-09-03
DTD32001-01-18
DRF22021-10-15
NIQ22019-02-22
LOX22017-01-26
DYB22016-01-11
MRM22006-08-10
DRB12019-08-01
NIP12017-03-23
MAF12017-02-14
NIO12015-12-17
NDN12013-05-20
DTC12009-04-01
NKE12008-05-12
LWS11998-10-27
DTE11997-07-10
DXY11996-10-11
LWP11984-02-15

PMA#

Protego EP PASSION

2023-01-16

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS170 Date Received11/30/2022 Decision Date01/16/2023 Product Code MRM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason ...

Protego EP PASSION

2023-01-16

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS118 Date Received11/30/2022 Decision Date01/16/2023 Product Code LWS  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason ...

Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U

2023-01-12

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS143 Date Received11/15/2022 Decision Date01/12/2023 Product Code NKE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/c...

Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U

2023-01-12

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS169 Date Received11/15/2022 Decision Date01/12/2023 Product Code MRM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/c...

Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U

2023-01-12

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP000009 Supplement NumberS100 Date Received11/15/2022 Decision Date01/12/2023 Product Code MRM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/c...

Drug-Eluting Permanent Defibrillator Electrodes

2022-12-16

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS117 Date Received11/23/2022 Decision Date12/16/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Pulse Generator, Permanent, Implantable

2022-12-07

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS241 Date Received11/10/2022 Decision Date12/07/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Implantable Cardioverter Defibrillator (Non-CRT)

2022-12-07

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS116 Date Received11/10/2022 Decision Date12/07/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Defibrillator, implantable, dual-chamber

2022-12-07

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP000009 Supplement NumberS099 Date Received11/10/2022 Decision Date12/07/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

DataBridge 4G/LTE Adapter

2022-12-02

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS240 Date Received09/26/2022 Decision Date12/02/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/c...

Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode

2022-11-16

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS141 Date Received10/18/2022 Decision Date11/16/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode

2022-10-20

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS140 Date Received09/22/2022 Decision Date10/20/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Permanent Defibrillator Electrodes

2022-10-20

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS115 Date Received09/22/2022 Decision Date10/20/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Pulse Generator, Permanent, Implantable

2022-09-15

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS238 Date Received08/29/2022 Decision Date09/15/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Astron Pulsar Stent System, Pulsar-18 Stent System

2022-07-27

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP160025 Supplement NumberS015 Date Received06/21/2022 Decision Date07/27/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

PRO-Kinetic Energy Coronary Stent System

2022-07-27

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP160003 Supplement NumberS015 Date Received06/21/2022 Decision Date07/27/2022 Product Code MAF  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Astron Peripheral Self-Expanding Nitinol Stent System

2022-07-27

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP140030 Supplement NumberS015 Date Received06/21/2022 Decision Date07/27/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Pulse Generator, Permanent, Implantable

2022-06-21

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS236 Date Received06/17/2022 Decision Date06/21/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Implantable Cardioverter Defibrillator (Non-CRT)

2022-06-21

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS114 Date Received06/17/2022 Decision Date06/21/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Defibrillator, Implantable, dual-chamber

2022-06-21

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP000009 Supplement NumberS098 Date Received06/17/2022 Decision Date06/21/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

Pulsar-18 Stent Systems

2022-05-20

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP160025 Supplement NumberS014 Date Received04/20/2022 Decision Date05/20/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

PSW 2201.U/1 and NEO 2201.U/1

2022-04-11

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS136 Date Received02/07/2022 Decision Date04/11/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/c...

PSW 2201.U/1 and NEO 2201.U/1

2022-04-11

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS166 Date Received02/07/2022 Decision Date04/11/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/c...

PSW 2201.U/1 and NEO 2201.U/1

2022-04-11

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP000009 Supplement NumberS097 Date Received02/07/2022 Decision Date04/11/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/c...

Drug-Eluting Permanent Defibrillator Electrodes

2022-03-15

BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS112 Date Received02/17/2022 Decision Date03/15/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

200 records. Showing 1-40. Next

PMN#

145 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next