BIOTRONIK, INC.

Matched from indexed company URL: BIOTRON LTD.

FDA Registration(s)#

Registration, FEI, Name table
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
3010131137	3010131137	BIOTRONIX HEALTHCARE INDUSTRIES INC.	1	Y	2026-01-01	4700 Millenia Blvd Ste 500 Orlando FL US 32839
3027063190	3027063190	BIOTRONIK NRO, INC.	1	Y	2026-01-01	6024 Jean Road Lake Oswego OR US 97035
3031755019	3031755019	Biotronics 3D Limited	1	N	2026-01-01	1 First Floor Offices, Suite 3 1 Duchess Street London London, City of GB W1W 6AN

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 GUDID	Product	Phone	Email
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

teleflex.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
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
154683	1424219406	K993118	BIOTEQUE A.V. FISTULA NEEDLE SET	FIE	1999-12-17
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
330299	2032916367	K240839	OpenRad Cloud	LLZ	2024-04-24
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
154683	1507583818	K223323	Blood Collection Needle (with/without Needle Holder)	JKA	2023-03-24
154683	1321395069	K222141	Safety Blood Collection Needle (Without Needle Holder)	JKA	2022-10-21
154683	1710232589	K222124	Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle	FMI	2022-11-04
28191	1382647764	K222037	Selectra Lead Implantation System	DQY	2022-07-19
28191	1775582339	K221856	BIOMONITOR IIIm, BIOMONITOR III	MXD	2022-07-27
154683	1546010858	K221521	Disposable Safety Lancet	FMK	2022-10-28
154683	1120345318	K214075	Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)	FMI	2022-04-12
28191	2015623492	K212593	ViaCath, AcQRate Dx Steerable Catheter	DRF	2021-10-15
154683	1868062168	K211555	Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe	MEG	2021-10-18
154683	2031020193	K210745	Heel Incision Safety Lancet	FMK	2021-08-26
154683	1385219970	K202698	Prefilled Syringe	EZL	2020-12-15
28191	1478818398	K201445	MultiCath, AcQRate Dx Fixed Curve Catheter	DRF	2021-09-02
28191	1816737245	K200444	Biomonitor III, Biomonitor IIIm	MXD	2020-04-23
154683	1783995716	K200027	Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter	JKA	2020-09-09
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
154683	1308500524	K192230	MF SAFECATH	FOZ	2020-04-23
28191	1095329053	K191469	Biotronik Stylets	DRB	2019-08-01
28191	2027468016	K190548	BIOMONITOR III, Remote Assistant III	MXD	2019-07-05
154683	1705465149	K190183	Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe	MEG	2019-10-04
28191	1310742017	K183265	Selectra Catheters, Selectra Accessory Kit	DQY	2018-12-13
154683	1208024196	K181276	CONOD Enteral Feeding Sets	PIF	2018-07-12
154683	2010917268	K173847	Disposable Ultra Reinforced Surgical Gown	FYA	2019-01-16
154683	1692396113	K172763	Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder	JKA	2018-06-04
83935	1657566336	K163660	Pantera LEO	LOX	2017-01-26
154683	1156928378	K162188	Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)	PNR	2016-09-22
83935	1056585236	K160985	Pantera Pro	LOX	2016-10-07
154683	1435944067	K153496	Disposable Surgical Face Mask	FXX	2016-06-15
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
154683	1023009379	K151991
28191	1632616329	K151409	Selectra Catheters and Selectra Accessory Kit	DQY	2015-08-07
28191	1092479465	K143503	BioMonitor	MXD	2015-03-19
154683	1232328157	K142797	I.V. Catheter	FOZ	2015-06-18
83935	1236732730	K142379	Passeo-35 PTA Catheter	LIT	2014-12-05
154683	1144679180	K140356	SUMMED HIGH PRESSURE LINE	DQO	2015-03-20
154683	1867776363	K140237	DISPOSABLE NEBULIZER SET	CAF	2015-01-08
154683	2026997030	K133795	SUMMED INFLATION DEVICE KIT	MAV	2014-12-12
154683	1999871467	K133343	WONDFO RAPID STREP A TEST	GTY	2014-01-31
154683	1788933873	K133058	INSULIN PEN NEEDLE	FMI	2014-02-25
154683	1075731459	K132709	VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER	CAH	2014-07-30
154683	1332878458	K131754	WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)	DIO	2013-07-31
154683	1415636358	K131511	DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR	GDW	2013-07-05
154683	1860856177	K130737	SYNTHETIC ABSORBABLE SUTURE	GAM	2014-01-14
154683	1836863314	K130735	SYNTHETIC ABSORBABLE SUTURE	GAM	2014-01-14
154683	1869697198	K130273	PANPAC VAGINAL DILATORS	HDX	2013-08-08
83935	1856160047	K130146	SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM	NDN	2013-05-20
154683	1481277705	K130087	PANPAC WORD/BARTHOLIN CATHETER	KNA	2014-01-10
154683	1179851529	K123475	SHOOCIN INTRODUCER KIT	DYB	2014-02-03
154683	1443827946	K123473	HOPER PTCA BALLOON CATHETER	LOX	2013-08-13
154683	1419404098	K123030	COMPRESSOR NEBULIZER MODEL MCN-S600XX	CAF	2013-12-19
154683	1754282578	K121474	DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER	GDW	2012-07-16
154683	1477699587	K120475	ANESTHESIA CONDUCTION NEEDLES	BSP	2012-12-21
154683	1689451744	K120119	SUNMED GUIDE WIRE	DQX	2012-05-11
28191	1248168846	K113468	ELM PTA BALLON DILATATION CATHETER	LIT	2011-12-20
83935	2044718311	K113468	ELM PTA BALLON DILATATION CATHETER	LIT	2011-12-20
154683	1183132224	K112204
154683	1539093019	K112057	KDL SYRINGES AND NEEDLE	FMF	2011-12-14
154683	1271522406	K111837	RADIAL ARTERY COMPRESSION TOURNIQUET	DXC	2011-09-27
154683	1473502596	K111559	SURGICAL MASKS	FXX	2011-09-16
154683	1164349444	K110853	VR MEDICAL ENTERAL ORAL SYRINGE	FPD	2011-05-13
154683	1508611908	K110421	DISPOSABLE INSULIN SYRINGE	FMF	2011-04-26
154683	1712040921	K110269	WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL	BTR	2011-08-26
154683	1583438641	K110182	CANNABINOIDS URINE TEST	LDJ	2011-05-20
154683	2022199172	K102898	BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE	LKF	2011-12-15
154683	1851985413	K102833	DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS	MPB	2011-11-18
154683	2005629314	K102372	OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB	GEI	2010-11-03
154683	1028118991	K102316	GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM	CGA	2011-10-07
83935	1802528173	K102211	CRUISER 18 GUIDEWIRE	DQX	2010-09-03
154683	1765517944	K101136	FISIO CHAMBER SPACE	NVP	2011-01-28
83935	1828161358	K100799	FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815	DYB	2011-02-25
154683	1288749777	K100723	DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5	GDW	2010-04-30
154683	1840105434	K093910	IMPROVACUTER GEL & CLOT ACTIVATOR TUBE	JKA	2010-07-12
154683	1135152512	K092984	PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0	LKF	2010-04-07
154683	1005158084	K092983	PANPAC HSG CATHETER SET	LKF	2010-06-07
154683	1575959213	K092982	THE PANPAC SUCTION CURETTE	HHK	2010-07-26
154683	1034958984	K092981	PANPAC VAGINAL PESSARY	HHW	2010-07-22
154683	1787975014	K092980	PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5	LKF	2010-03-11
154683	1852657256	K092886	WELL LEAD ENDOBRONCHIAL TUBES	CBI	2010-03-11
154683	1333611939	K092634	OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF	GEI	2009-12-01
154683	2024517951	K091516	WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR	EZL	2009-10-16
83935	1961452980	K090193	CONDUCTOR CORONARY GUIDEWIRE	DQX	2009-09-25
154683	1679473402	K083687	BAIXIN INTRAVASCULAR ADMINISTRATION SET	FPA	2009-06-11
28191	1467190724	K083674	PK-141 PATIENT CABLE	DTC	2009-04-01
154683	1704221166	K083429	I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT	FOZ	2009-08-07
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
154683	1650705880	K082815	WELL LEAD SILICONE AND LATEX FOLEY CATHETERS	EZL	2008-10-08
154683	1388901649	K082439	DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT	DXT	2009-03-23
154683	1433362342	K080684	WG-SURGICAL SUTURES WITH NEEDLE	GAP	2008-06-09
154683	1224813831	K073614	WG-SURGICAL SUTURES WITH NEEDLE	NEW	2008-04-30
154683	1403416607	K073383	WELL LEAD REINFORCED ENDOTRACHEAL TUBE	BTR	2008-07-10
154683	1602669815	K073127	BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G	FMI	2007-12-20
83935	1317498973	K072765	PASSEO 18	LIT	2007-12-12
154683	2050489939	K072739	JIERUI SYRINGES AND NEEDLES	MEG	2008-03-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LIT	8	2025-04-04
DQY	7	2024-09-12
DQX	7	2012-05-11
MXD	6	2023-05-19
FMI	6	2022-11-04
JKA	5	2023-03-24
FOZ	5	2020-04-23
LKF	4	2011-12-15
MEG	3	2021-10-18
EZL	3	2020-12-15
LOX	3	2017-01-26
DYB	3	2016-01-11
GAM	3	2014-01-14
GDW	3	2013-07-05
FMF	3	2011-12-14
BTR	3	2011-08-26
DTD	3	2001-01-18
FMK	2	2022-10-28
DRF	2	2021-10-15
NIQ	2	2019-02-22
FXX	2	2016-06-15
CAF	2	2015-01-08
GEI	2	2010-11-03
GAP	2	2008-06-09
NEW	2	2008-04-30
MRM	2	2006-08-10
LCX	2	2006-07-18
KGO	2	2003-10-17
LYY	2	2002-01-17
LLZ	1	2024-04-24
DRB	1	2019-08-01
FYA	1	2019-01-16
PIF	1	2018-07-12
NIP	1	2017-03-23
MAF	1	2017-02-14
PNR	1	2016-09-22
NIO	1	2015-12-17
DQO	1	2015-03-20
MAV	1	2014-12-12
CAH	1	2014-07-30

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...
Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes
2022-12-16
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...
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...
Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp
2022-12-07
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...
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P)
2022-12-07
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...
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 Right Ventricular (RV), Right Atrial (RA) Pacemaker Electrodes
2022-10-20
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...
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, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P)
2022-09-15
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...
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...
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
2022-08-22
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...
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
2022-08-22
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...
Orsiro Mission Sirolimus Eluting Coronary Stent System, Orsiro Sirolimus Eluting Coronary Stent System
2022-08-05
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...
Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System
2022-07-27
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...
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...
Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-DP)
2022-06-21
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...
Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic Def
2022-06-21
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...
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...
Drug Eluting Permanent Right Ventricular/Right Atrial Pacemaker Electrodes
2022-03-15
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...
Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX,
2022-03-08
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...
Siello S 45/Solia S 45, Siello S 53/Solia S 53, Siello S 60/Solia S 60
2022-03-04
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 ...
Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR
2022-02-28
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...

200 records. Showing 1-40. Next

PMN#

Pantera Pro; Pantera LEO
2024-10-25
Biotronik, Inc.
Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)
2024-09-12
Biotronik, Inc.
Oscar Peripheral Multifunctional Catheter system
2024-07-11
Biotronik, Inc.
BIOMONITOR IV
2023-05-19
Biotronik, Inc.
Passeo-35 Xeo Peripheral Dilatation Catheter
2023-02-16
Biotronik, Inc.
BIOMONITOR IIIm, BIOMONITOR III
2022-07-27
BIOTRONIK, Inc.
Selectra Lead Implantation System
2022-07-19
Biotronik, Inc.
Oscar Peripheral Multifunctional Catheter System
2022-07-06
BIOTRONIK, Inc.
ViaCath, AcQRate Dx Steerable Catheter
2021-10-15
Biotronick, Inc.
MultiCath, AcQRate Dx Fixed Curve Catheter
2021-09-02
Biotronik, Inc
Biomonitor III, Biomonitor IIIm
2020-12-08
Biotronik, Inc.
Selectra 3D Outer Guiding Catheters
2020-10-16
BIOTRONIK, Inc
Biomonitor III, Biomonitor IIIm
2020-04-23
BIOTRONIK, Inc.
Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool
2019-11-21
Biotronik, Inc
Biotronik Stylets
2019-08-01
Biotronik, Inc
BIOMONITOR III, Remote Assistant III
2019-07-05
Biotronik, Inc.
Selectra Catheters, Selectra Accessory Kit
2018-12-13
Biotronik, Inc.
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
2017-06-29
BIOTRONIK, Inc.
BioMonitor 2-AF, BioMonitor 2-S
2017-03-31
BIOTRONIK, Inc
Pantera LEO
2017-01-26
BIOTRONIK, INC.
Pantera Pro
2016-10-07
BIOTRONIK, INC
BioMonitor 2-AF, BioMonitor 2-S
2016-04-11
BIOTRONIK, INC.
Passeo-14 Peripheral Dilatation Catheter
2015-10-08
BIOTRONIK, INC.
Passeo-18 Peripheral Dilation Catheter
2015-10-08
BIOTRONIK, INC.
Selectra Catheters And Selectra Accessory Kit
2015-08-07
BIOTRONIK, INC.
BioMonitor
2015-03-19
BIOTRONIK, INC.
Passeo-35 PTA Catheter
2014-12-05
BIOTRONIK, INC.
BIOMONITOR
2014-06-06
BIOTRONIK, INC.
SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL
2013-08-23
BIOTRONIK, INC.
PASSEO-35
2013-04-23
BIOTRONIK, INC.
SELECTRA 7F CATHETERS
2013-01-11
BIOTRONIK, INC.
SELECTRA ACCESSORY KIT
2011-09-26
BIOTRONIK, INC.
SELECTRA SLITTER TOOL
2011-09-26
BIOTRONIK, INC.
SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75
2011-05-23
BIOTRONIK, INC.
SELECTRA CS LEAD INTRODUCER SYSTEM
2011-04-20
BIOTRONIK, INC.
SCOUTPRO ACS
2010-07-23
BIOTRONIK, INC.
SCOUTPRO HEMOSTATIC VALVE
2010-07-21
BIOTRONIK, INC.
SCOUTPRO 7F LONG CATHETERS
2009-11-20
BIOTRONIK, INC.
PK-141 PATIENT CABLE
2009-04-01
BIOTRONIK, INC.
VISION WIRE CORONARY GUIDEWIRE
2008-12-04
BIOTRONIK, INC.

156 records. Showing 1-40. Next

GUDID#

Passeo-14 - 3/220/150
Biotronik AG
2016-08-18
Passeo-14 - 2.5/220/150
Biotronik AG
2016-08-18
Passeo-14 - 2/220/150
Biotronik AG
2016-08-18
Passeo-14 - 3/180/150
Biotronik AG
2016-08-18
Passeo-14 - 2.5/180/150
Biotronik AG
2016-08-18
Passeo-14 - 2/180/150
Biotronik AG
2016-08-18
Passeo-14 - 4/140/150
Biotronik AG
2016-08-18
Passeo-14 - 3.5/140/150
Biotronik AG
2016-08-18
Passeo-14 - 3/140/150
Biotronik AG
2016-08-18
Passeo-14 - 2.5/140/150
Biotronik AG
2016-08-18
Passeo-14 - 2/140/150
Biotronik AG
2016-08-18
Passeo-14 - 4/100/150
Biotronik AG
2016-08-18
Passeo-14 - 3.5/100/150
Biotronik AG
2016-08-18
Passeo-14 - 3/100/150
Biotronik AG
2016-08-18
Passeo-14 - 2.5/100/150
Biotronik AG
2016-08-18
Passeo-14 - 2/100/150
Biotronik AG
2016-08-18
Passeo-14 - 4/70/150
Biotronik AG
2016-08-18
Passeo-14 - 3.5/70/150
Biotronik AG
2016-08-18
Passeo-14 - 3/70/150
Biotronik AG
2016-08-18
Passeo-14 - 2.5/70/150
Biotronik AG
2016-08-18
Passeo-14 - 2/70/150
Biotronik AG
2016-08-18
Passeo-14 - 1.5/70/150
Biotronik AG
2016-08-18
Passeo-14 - 4/40/150
Biotronik AG
2016-08-18
Passeo-14 - 3.5/40/150
Biotronik AG
2016-08-18
Passeo-14 - 3/40/150
Biotronik AG
2016-08-18
Passeo-14 - 2.5/40/150
Biotronik AG
2016-08-18
Passeo-14 - 2/40/150
Biotronik AG
2016-08-18
Passeo-14 - 1.5/40/150
Biotronik AG
2016-08-18
Passeo-14 - 4/20/150
Biotronik AG
2016-08-18
Passeo-14 - 3.5/20/150
Biotronik AG
2016-08-18
Passeo-14 - 3/20/150
Biotronik AG
2016-08-18
Passeo-14 - 2.5/20/150
Biotronik AG
2016-08-18
Passeo-14 - 2/20/150
Biotronik AG
2016-08-18
Passeo-14 - 1.5/20/150
Biotronik AG
2016-08-18
Passeo-14 - 3/220/90
Biotronik AG
2016-08-18
Passeo-14 - 2.5/220/90
Biotronik AG
2016-08-18
Passeo-14 - 2/220/120
Biotronik AG
2016-08-18
Passeo-14 - 3/180/90
Biotronik AG
2016-08-18
Passeo-14 - 2.5/180/90
Biotronik AG
2016-08-18
Passeo-14 - 2/180/120
Biotronik AG
2016-08-18

80 records. Showing 1-40. Next