| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1028232 | 1028232 | BIOTRONIK, INC. | 1 | Y | 2026-01-01 | 6024 JEAN RD. LAKE OSWEGO OR US 97035 |
| 8043892 | 3002808050 | BIOTRONIK AG | 1 | N | 2026-01-01 | ACKERSTRASSE 6 BULACH Zurich CH CH-8180 |
| 3027063190 | 3027063190 | BIOTRONIK NRO, INC. | 1 | Y | 2026-01-01 | 6024 Jean Road Lake Oswego OR US 97035 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07640130433779 | Passeo-14 - 3.5/140/150 | 612-423-1738 | FDA.US.Agent@teleflex.com |
| 07640130433786 | Passeo-14 - 4/140/150 | 612-423-1738 | FDA.US.Agent@teleflex.com |
| 07640130433809 | Passeo-14 - 2/180/150 | 612-423-1738 | FDA.US.Agent@teleflex.com |
| 07640130433816 | Passeo-14 - 2.5/180/150 | 612-423-1738 | FDA.US.Agent@teleflex.com |
| 07640130433823 | Passeo-14 - 3/180/150 | 612-423-1738 | FDA.US.Agent@teleflex.com |
| 07640130433861 | Passeo-14 - 2/220/150 | 612-423-1738 | FDA.US.Agent@teleflex.com |
| 07640130433878 | Passeo-14 - 2.5/220/150 | 612-423-1738 | FDA.US.Agent@teleflex.com |
| 07640130433885 | Passeo-14 - 3/220/150 | 612-423-1738 | FDA.US.Agent@teleflex.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 28191 | 1713920620 | P980023 | PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM | LWS | 1998-10-27 |
| 28191 | 1309454949 | P950037 | DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS | DXY | 1996-10-11 |
| 28191 | 1723237467 | P820076 | DIPLOS MODEL 05 A & B | LWP | 1984-02-15 |
| 316196 | 2054914776 | P210037 | Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management | LGW | 2023-03-31 |
| 28191 | 1234382442 | P170030 | ORSIRO Sirolimus Eluting Coronary Stent System | NIQ | 2019-02-22 |
| 83935 | 1263247262 | P170030 | ORSIRO Sirolimus Eluting Coronary Stent System | NIQ | 2019-02-22 |
| 83935 | 1895965527 | P160025 | ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM | NIP | 2017-03-23 |
| 83935 | 1632727540 | P160003 | PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM | MAF | 2017-02-14 |
| 83935 | 1793172198 | P140030 | ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM | NIO | 2015-12-17 |
| 28191 | 1183288798 | P070008 | STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD | NKE | 2008-05-12 |
| 28191 | 1754526466 | P050023 | TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD | MRM | 2006-08-10 |
| 28191 | 1874963309 | P000009 | PHYLAX AV ICD SYSTEM | MRM | 2000-09-29 |
| 28191 | 1843737205 | K982272 | GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018 | DQX | 1999-01-08 |
| 28191 | 1413560754 | K971930 | BK-N SEALING CAP | DTD | 1997-08-14 |
| 28191 | 1436236894 | K970204 | BK-A; BK-B; BK-IS SEALING CAP | DTD | 1997-04-29 |
| 28191 | 1853114577 | K964190 | ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER | DTE | 1997-07-10 |
| 83935 | 1284326705 | K250706 | Passeo-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) Catheter | LIT | 2025-04-04 |
| 28191 | 1998574796 | K250706 | Passeo-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) Catheter | LIT | 2025-04-04 |
| 28191 | 1336713106 | K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) | DQY | 2024-09-12 |
| 28191 | 1437751083 | K230375 | BIOMONITOR IV | MXD | 2023-05-19 |
| 28191 | 1382647764 | K222037 | Selectra Lead Implantation System | DQY | 2022-07-19 |
| 28191 | 1775582339 | K221856 | BIOMONITOR IIIm, BIOMONITOR III | MXD | 2022-07-27 |
| 28191 | 2015623492 | K212593 | ViaCath, AcQRate Dx Steerable Catheter | DRF | 2021-10-15 |
| 28191 | 1478818398 | K201445 | MultiCath, AcQRate Dx Fixed Curve Catheter | DRF | 2021-09-02 |
| 28191 | 1816737245 | K200444 | Biomonitor III, Biomonitor IIIm | MXD | 2020-04-23 |
| 28191 | 1985179832 | K193474 | Selectra 3D Outer Guiding Catheters | DQY | 2020-10-16 |
| 28191 | 1254174487 | K192996 | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool | DQY | 2019-11-21 |
| 28191 | 1095329053 | K191469 | Biotronik Stylets | DRB | 2019-08-01 |
| 28191 | 2027468016 | K190548 | BIOMONITOR III, Remote Assistant III | MXD | 2019-07-05 |
| 28191 | 1310742017 | K183265 | Selectra Catheters, Selectra Accessory Kit | DQY | 2018-12-13 |
| 83935 | 1657566336 | K163660 | Pantera LEO | LOX | 2017-01-26 |
| 83935 | 1056585236 | K160985 | Pantera Pro | LOX | 2016-10-07 |
| 83935 | 1855338479 | K153197 | Fortress Introducer Sheath SYstem | DYB | 2016-01-11 |
| 28191 | 1108246177 | K152995 | BioMonitor 2-AF, BioMonitor 2-S | MXD | 2016-04-11 |
| 83935 | 1927430492 | K152240 | Passeo-14 Peripheral Dilatation Catheter | LIT | 2015-10-08 |
| 28191 | 1632616329 | K151409 | Selectra Catheters and Selectra Accessory Kit | DQY | 2015-08-07 |
| 28191 | 1092479465 | K143503 | BioMonitor | MXD | 2015-03-19 |
| 83935 | 1236732730 | K142379 | Passeo-35 PTA Catheter | LIT | 2014-12-05 |
| 83935 | 1856160047 | K130146 | SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM | NDN | 2013-05-20 |
| 28191 | 1248168846 | K113468 | ELM PTA BALLON DILATATION CATHETER | LIT | 2011-12-20 |
| 83935 | 2044718311 | K113468 | ELM PTA BALLON DILATATION CATHETER | LIT | 2011-12-20 |
| 83935 | 1802528173 | K102211 | CRUISER 18 GUIDEWIRE | DQX | 2010-09-03 |
| 83935 | 1828161358 | K100799 | FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 | DYB | 2011-02-25 |
| 83935 | 1961452980 | K090193 | CONDUCTOR CORONARY GUIDEWIRE | DQX | 2009-09-25 |
| 28191 | 1467190724 | K083674 | PK-141 PATIENT CABLE | DTC | 2009-04-01 |
| 28191 | 1277664842 | K083094 | STREAMER POLYMER GUIDEWIRE | DQX | 2009-07-07 |
| 28191 | 1084472692 | K082935 | VISION WIRE CORONARY GUIDEWIRE | DQX | 2008-12-04 |
| 83935 | 2072213833 | K082933 | PASSEO-35 PTA CATHETER | DQY | 2008-11-03 |
| 83935 | 1317498973 | K072765 | PASSEO 18 | LIT | 2007-12-12 |
| 28191 | 1880553209 | K003454 | A1-CS-SB Y-ADAPTER, MODEL 124 871 | DTD | 2001-01-18 |
| 28191 | 1508469563 | K001736 | GALEO HYDRO AND GALEO HYDRO J-TIP | DQX | 2000-08-02 |
| 83935 | 1038367706 | H170004 | |||
| 28191 | 1389265553 | H170004 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LIT | 8 | 2025-04-04 |
| DQY | 7 | 2024-09-12 |
| MXD | 6 | 2023-05-19 |
| DQX | 6 | 2010-09-03 |
| DTD | 3 | 2001-01-18 |
| DRF | 2 | 2021-10-15 |
| NIQ | 2 | 2019-02-22 |
| LOX | 2 | 2017-01-26 |
| DYB | 2 | 2016-01-11 |
| MRM | 2 | 2006-08-10 |
| DRB | 1 | 2019-08-01 |
| NIP | 1 | 2017-03-23 |
| MAF | 1 | 2017-02-14 |
| NIO | 1 | 2015-12-17 |
| NDN | 1 | 2013-05-20 |
| DTC | 1 | 2009-04-01 |
| NKE | 1 | 2008-05-12 |
| LWS | 1 | 1998-10-27 |
| DTE | 1 | 1997-07-10 |
| DXY | 1 | 1996-10-11 |
| LWP | 1 | 1984-02-15 |
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 ...
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 ...
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...
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...
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...
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...
BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS243 Date Received11/23/2022 Decision Date12/16/2022 Product Code DXY Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...
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...
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...
BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS168 Date Received11/10/2022 Decision Date12/07/2022 Product Code MRM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...
BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS142 Date Received11/10/2022 Decision Date12/07/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...
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...
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...
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...
BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS239 Date Received09/22/2022 Decision Date10/20/2022 Product Code DXY Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...
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...
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...
BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS139 Date Received08/29/2022 Decision Date09/15/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...
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...
BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS237 Date Received08/03/2022 Decision Date08/22/2022 Product Code DXY Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...
BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS138 Date Received08/03/2022 Decision Date08/22/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...
Biotronik, Inc6024 Jean Roadlake Oswego, OR 97035 PMA NumberP170030 Supplement NumberS026 Date Received07/07/2022 Decision Date08/05/2022 Product Code NIQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Man...
Biotronik, Inc6024 Jean Roadlake Oswego, OR 97035 PMA NumberP170030 Supplement NumberS024 Date Received06/21/2022 Decision Date07/27/2022 Product Code NIQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Man...
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...
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...
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...
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...
BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS137 Date Received06/17/2022 Decision Date06/21/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...
BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS167 Date Received06/17/2022 Decision Date06/21/2022 Product Code MRM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...
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...
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...
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...
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...
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...
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...
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...
BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS235 Date Received02/17/2022 Decision Date03/15/2022 Product Code DXY Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...
BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS165 Date Received12/08/2021 Decision Date03/08/2022 Product Code MRM Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/c...
BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS233 Date Received01/05/2022 Decision Date03/04/2022 Product Code DXY Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason ...
BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS135 Date Received02/01/2022 Decision Date02/28/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...
Biotronik, Inc.
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teleflex.com