CardioMessenger Smart 4G
BIOTRONIK, INC.
BIOTRONIK, INC.
FDA Registration(s)#
| 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 |
Registered Device Listings#
| 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 |
| 28191 | 1234382442 | P170030 | ORSIRO Sirolimus Eluting Coronary Stent System | NIQ | 2019-02-22 |
| 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 |
| 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 |
| 28191 | 1108246177 | K152995 | BioMonitor 2-AF, BioMonitor 2-S | MXD | 2016-04-11 |
| 28191 | 1632616329 | K151409 | Selectra Catheters and Selectra Accessory Kit | DQY | 2015-08-07 |
| 28191 | 1092479465 | K143503 | BioMonitor | MXD | 2015-03-19 |
| 28191 | 1248168846 | K113468 | ELM PTA BALLON DILATATION CATHETER | LIT | 2011-12-20 |
| 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 |
| 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 |
| 28191 | 1389265553 | H170004 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DQY | 6 | 2024-09-12 |
| MXD | 6 | 2023-05-19 |
| DQX | 4 | 2009-07-07 |
| DTD | 3 | 2001-01-18 |
| LIT | 2 | 2025-04-04 |
| DRF | 2 | 2021-10-15 |
| MRM | 2 | 2006-08-10 |
| DRB | 1 | 2019-08-01 |
| NIQ | 1 | 2019-02-22 |
| 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 |
PMA#
Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos
BIOTRONIK, INC.
Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico
BIOTRONIK, INC.
Drug-Eluting Permanent Defibrillator Electrodes
BIOTRONIK, INC.
Siello T/JT, Solia T/JT, Siello S, Solia S, Evia DR, Evia DR-T, Evia SR, Entovis DR, Entovis DR-T, Entovis SR, Entovis S
BIOTRONIK, INC.
Sentus ProMRI OTW QP S, Sentus ProMRI OTW QP S-xx/49, Sentus ProMRI OTW QP L, Sentus ProMRI OTW QP Lxx/49m, Evia HF, Evi
BIOTRONIK, INC.
PHYLAX AV ICD SYSTEM
BIOTRONIK, INC.
Iforia 7, Ilesto 5, Iforia 5, Itrevia 7, Iperia 7, Ilivia 7, Intica 7, Intica 5, Inlexa 3, Inventra 7, Itrevia 5, Iperia
BIOTRONIK, INC.
Astron Peripheral Self-Expanding Nitinol Stent System
BIOTRONIK, INC.
Astron Pulsar Stent System
BIOTRONIK, INC.
Sentus QP leads
BIOTRONIK, INC.
Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T (
BIOTRONIK, INC.
Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T
BIOTRONIK, INC.
Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T (
BIOTRONIK, INC.
Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-
BIOTRONIK, INC.
Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T
BIOTRONIK, INC.
CardioMessenger Smart 4G
BIOTRONIK, INC.
Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T
BIOTRONIK, INC.
Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T (
BIOTRONIK, INC.
Evia HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Eni
BIOTRONIK, INC.
Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-
BIOTRONIK, INC.
Evia SR-T, Evia SR, Evia DR-T, Evia DR, Entovis SR-T, Entovis DR-T, Entovis DR, Estella SR-T, Estella DR-T, Estella DR,
BIOTRONIK, INC.
PRO-Kinetic Energy Coronary Stent System
BIOTRONIK, INC.
Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes
BIOTRONIK, INC.
Pulse Generator, Permanent, Implantable
BIOTRONIK, INC.
Pulse Generator, Permanent, Implantable
BIOTRONIK, INC.
Defibrillator, Automatic Implantable Crdioveter, with Cardiac Resynchronization (CRT-D), Defibrillator, Implantable Dual
BIOTRONIK, INC.
Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber and Defibrillator, automatic
BIOTRONIK, INC.
Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P)
BIOTRONIK, INC.
Defibrillator, Implantable Dual-Chamber
BIOTRONIK, INC.
Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P)
BIOTRONIK, INC.
PRO-Kinetic Energy Coronary Stent System
BIOTRONIK, INC.
Astron Pulsar Stent System
BIOTRONIK, INC.
Astron Peripheral Self- Expanding Nitinol Stent System
BIOTRONIK, INC.
PSW 2100.U and NEO 2100.U
BIOTRONIK, INC.
PSW 2100.U and NEO 2100.U
BIOTRONIK, INC.
PSW 2100.U and NEO 2100.U
BIOTRONIK, INC.
Astron Pulsar Stent System and Pulsar-18 Stent System
BIOTRONIK, INC.
PRO-Kinetic Energy Coronary Stent System
BIOTRONIK, INC.
Astron Peripheral Self-Expanding Nitinol Stent System
BIOTRONIK, INC.
PMN#
Pantera Pro; Pantera LEO
Biotronik, Inc.
Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)
Biotronik, Inc.
Oscar Peripheral Multifunctional Catheter system
Biotronik, Inc.
BIOMONITOR IV
Biotronik, Inc.
Passeo-35 Xeo Peripheral Dilatation Catheter
Biotronik, Inc.
BIOMONITOR IIIm, BIOMONITOR III
BIOTRONIK, Inc.
Selectra Lead Implantation System
Biotronik, Inc.
Oscar Peripheral Multifunctional Catheter System
BIOTRONIK, Inc.
Biomonitor III, Biomonitor IIIm
Biotronik, Inc.
Biomonitor III, Biomonitor IIIm
BIOTRONIK, Inc.
BIOMONITOR III, Remote Assistant III
Biotronik, Inc.
Selectra Catheters, Selectra Accessory Kit
Biotronik, Inc.
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
BIOTRONIK, Inc.
Pantera LEO
BIOTRONIK, INC.
BioMonitor 2-AF, BioMonitor 2-S
BIOTRONIK, INC.
Passeo-18 Peripheral Dilation Catheter
BIOTRONIK, INC.
Passeo-14 Peripheral Dilatation Catheter
BIOTRONIK, INC.
Selectra Catheters And Selectra Accessory Kit
BIOTRONIK, INC.
BioMonitor
BIOTRONIK, INC.
Passeo-35 PTA Catheter
BIOTRONIK, INC.
BIOMONITOR
BIOTRONIK, INC.
SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL
BIOTRONIK, INC.
PASSEO-35
BIOTRONIK, INC.
SELECTRA 7F CATHETERS
BIOTRONIK, INC.
SELECTRA SLITTER TOOL
BIOTRONIK, INC.
SELECTRA ACCESSORY KIT
BIOTRONIK, INC.
SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75
BIOTRONIK, INC.
SELECTRA CS LEAD INTRODUCER SYSTEM
BIOTRONIK, INC.
SCOUTPRO ACS
BIOTRONIK, INC.
SCOUTPRO HEMOSTATIC VALVE
BIOTRONIK, INC.
SCOUTPRO 7F LONG CATHETERS
BIOTRONIK, INC.
PK-141 PATIENT CABLE
BIOTRONIK, INC.
VISION WIRE CORONARY GUIDEWIRE
BIOTRONIK, INC.
PASSEO-35 PTA CATHETER
BIOTRONIK, INC.
SCOUTPRO CS LEAD INTRODUCER SYSTEM
BIOTRONIK, INC.
SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED
BIOTRONIK, INC.
MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS
BIOTRONIK, INC.
PASSEO 18
BIOTRONIK, INC.
SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552
BIOTRONIK, INC.
BIOTRONIK ENDOCARDIAL PACING LEADS
BIOTRONIK, INC.