BIOTRONIK, INC

FDA Filings

This page includes the latest FDA filings for BIOTRONIK, INC. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Biotronik, Inc
Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool2019-11-21
Biotronik, Inc
Biotronik Stylets2019-08-01
Biotronik, Inc.
BIOMONITOR III, Remote Assistant III2019-07-05
Biotronik, Inc.
Selectra Catheters, Selectra Accessory Kit2018-12-13
BIOTRONIK, INC
Pantera Pro2016-10-07

Latest Premarket Applications

PMAManufacturerDevice NameDate
Biotronik, Inc
Orsiro Sirolimus Eluting Coronary Stent System2019-10-25
BIOTRONIK, INC.
Pulse Generator, Permanent Implantable, Pulse-Gererator, Pacemaker External, Adapter and Drug Eluting Permanent Right Ve2019-10-18
BIOTRONIK, INC.
Permanent Defibrillator Electrodes, Accessories to Permanent Pacemaker Electrode and Styley Catheter2019-10-18
BIOTRONIK, INC.
Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, dual chamber, Defibrillator, automatic imp2019-10-18
BIOTRONIK, INC.
Pulse Generator, Pacemaker Implantble with Cardiac Resynchronization (CRT-P) and Drug Eluting Permanent Left Ventricular2019-10-18
BIOTRONIK, INC.
DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS2019-10-04
BIOTRONIK, INC.
PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM2019-10-04
BIOTRONIK, INC.
Corox OTW BP2019-10-04
BIOTRONIK, INC.
STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD2019-10-04
BIOTRONIK, INC.
PHYLAX AV ICD SYSTEM2019-10-04
BIOTRONIK, INC.
CardioMessenger Smart 3G2019-09-16
BIOTRONIK, INC.
Ilivia Neo 7 HF -T, Intica Neo 7 and 5 HF -T, Ilivia Neo 7 HF -T QP, and Intica Neo 7 and 5 HF -T QP2019-09-04
BIOTRONIK, INC.
Ilivia Neo 7 VR-T, Intica Neo 7 and 5 VR-T, Ilivia Neo 7 VR-T DX, and Intica Neo 7 and 5 VR-T DX2019-09-04
BIOTRONIK, INC.
Ilivia Neo 7 DR-T and Intica Neo 7 and 5 DR-T2019-09-04
Biotronik, Inc
Orsiro Sirolimus Eluting Coronary Stent System2019-08-29
BIOTRONIK, INC.
Astron Peripheral Self-Expanding Nitinol Stent System2019-08-14
BIOTRONIK, INC.
Astron Pulsar/Pulsar-18 Stent Systems2019-08-14
BIOTRONIK, INC.
Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P)2019-07-19
BIOTRONIK, INC.
Pulse Generator, Permanent, Inplantable2019-07-19
BIOTRONIK, INC.
PSW 1901.U2019-07-18
BIOTRONIK, INC.
PSW 1901.U2019-07-18
BIOTRONIK, INC.
PRO-Kinetic Energy Coronary Stent System, Papyrus2019-06-05
BIOTRONIK, INC.
Phylax ICD System2019-05-24
BIOTRONIK, INC.
Tupos LV/ATx and Kronos LV-T CRT-D System2019-05-07
BIOTRONIK, INC.
Pulse Geneerator, Permanent, Implantable2019-05-07
BIOTRONIK, INC.
Stratos LV/LV-T CRT-P System2019-05-07
BIOTRONIK, INC.
Setrox S 53; Safio S 53; Dextrus 4136;TILDA R53;Solia S 45/53/60, JT 45/53; Siello S53/60/45/53/60/,JT 45/53;2019-04-29
BIOTRONIK, INC.
PRO-Kinetic Energy Coronary Stent System2019-04-25
BIOTRONIK, INC.
Sentus ProMRI OTW QP S-75, 85, 95, L-75, 85, 95, Sentus ProMRI OTW QP S-75/49, 85/49, 95/49, L-75/49, 85/49, 9/49 and Se2019-04-16
BIOTRONIK, INC.
Protego TD, SD 75/18, 65/18, 65/16 and SD 60/16 Protego T 65, and S 75, 65, 60 Plexa S 60, PLexa SD 60/16, Plexa ProMRI2019-04-16

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Home Monitoring Service Center
BIOTRONIK SE & Co. KG2019-11-04
Rivacor 3 VR-T
BIOTRONIK SE & Co. KG2019-10-28
Rivacor 3 DR-T
BIOTRONIK SE & Co. KG2019-10-28
Rivacor 3 HF-T
BIOTRONIK SE & Co. KG2019-10-28
Rivacor 3 HF-T QP
BIOTRONIK SE & Co. KG2019-10-28
Rivacor 5 VR-T
BIOTRONIK SE & Co. KG2019-10-28
Rivacor 5 VR-T DX
BIOTRONIK SE & Co. KG2019-10-28
Rivacor 5 DR-T
BIOTRONIK SE & Co. KG2019-10-28
Rivacor 5 HF-T
BIOTRONIK SE & Co. KG2019-10-28
Rivacor 5 HF-T QP
BIOTRONIK SE & Co. KG2019-10-28
Rivacor 7 VR-T
BIOTRONIK SE & Co. KG2019-10-28
Rivacor 7 VR-T DX
BIOTRONIK SE & Co. KG2019-10-28
Rivacor 7 DR-T
BIOTRONIK SE & Co. KG2019-10-28
Rivacor 7 HF-T
BIOTRONIK SE & Co. KG2019-10-28
Rivacor 7 HF-T QP
BIOTRONIK SE & Co. KG2019-10-28
Acticor 7 VR-T
BIOTRONIK SE & Co. KG2019-10-28
Acticor 7 VR-T DX
BIOTRONIK SE & Co. KG2019-10-28
Acticor 7 DR-T
BIOTRONIK SE & Co. KG2019-10-28
Acticor 7 HF-T
BIOTRONIK SE & Co. KG2019-10-28
Acticor 7 HF-T QP
BIOTRONIK SE & Co. KG2019-10-28
BIOTRONIK
BIOTRONIK SE & Co. KG2019-10-28
S 85-K OTW
BIOTRONIK SE & Co. KG2019-10-28
S 85-G OTW
BIOTRONIK SE & Co. KG2019-10-28
S 75-K OTW
BIOTRONIK SE & Co. KG2019-10-28
S 75-G OTW
BIOTRONIK SE & Co. KG2019-10-28
EFH-16
BIOTRONIK SE & Co. KG2019-10-28
Intica 7 VR-T DX
BIOTRONIK SE & Co. KG2019-10-28
Intica 7 HF-T QP
BIOTRONIK SE & Co. KG2019-10-28
Intica 7 HF-T
BIOTRONIK SE & Co. KG2019-10-28
Ilivia 7 VR-T
BIOTRONIK SE & Co. KG2019-10-28
Ilivia 7 VR-T
BIOTRONIK SE & Co. KG2019-10-28
Ilivia 7 DR-T
BIOTRONIK SE & Co. KG2019-10-28
Ilivia 7 DR-T
BIOTRONIK SE & Co. KG2019-10-28
Ilivia 7 HF-T QP
BIOTRONIK SE & Co. KG2019-10-28
BIOTRONIK
BIOTRONIK SE & Co. KG2019-10-28

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