FDA.reportPublic FDA data

St. Jude Medical, Atrial Fibrillation Division, Inc.

Matched from indexed company URL: St. Jude Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21822692182269St. Jude Medical, Atrial Fibrillation Division, Inc.1Y2026-01-0114901 DEVEAU PL. Minnetonka MN US 55345
21841491000139754St. Jude Medical, Atrial Fibrillation Division, Inc.1Y2026-01-01One St. Jude Medical Drive Saint Paul MN US 55117
30018831443001883144St. Jude Medical Brasil Ltda.1N2026-01-01Rua Professor Jos� Vieira de Mendon�a, 1301 Bairro Engenho Nogueira Belo Horizonte Minas Gerais BR 31.310-260
30053341383005334138St. Jude Medical, Cardiology Division, Inc.1Y2026-01-015050 Nathan Lane North Plymouth MN US 55442
30121797283012179728St. Jude Medical1Y2026-01-012305 Walnut Street Roseville MN US 55113
30125525323012552532St. Jude Medical Coordination Center BVBA European Distribution Center1N2026-01-01BruCargo 831 BruCargo Vlaams Brabant BE 1931
29388362938836St. Jude Medical, Implantable Electronic Systems Division1N2020-04-25645 Almanor Ave Sunnyvale CA US 94085

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
05414734001045Pacel™ - Flow Directed Pacing Catheter+1(855)478-5833customerservice@sjm.com
05414734001236Pacel™ - Bipolar Pacing Catheter+1(855)478-5833customerservice@sjm.com
05414734007856Pacel™ - Flow Directed Pacing Catheter+1(855)478-5833customerservice@sjm.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1619551609226794P970013MICRONY PACEMAKERSLWO2000-12-21
1619551949371366P960030PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADSNVN1998-01-29
59341501640764P960016LIVEWIRE(R) CARDIAC ABLATION SYSTEMLPB1999-05-04
59351501640764P960016LIVEWIRE(R) CARDIAC ABLATION SYSTEMLPB1999-05-04
1619551501640764P960016LIVEWIRE(R) CARDIAC ABLATION SYSTEMLPB1999-05-04
1881691501640764P960016LIVEWIRE(R) CARDIAC ABLATION SYSTEMLPB1999-05-04
1619551615224818P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSNVN1997-06-20
1475591405123025P950022TVL(TM) LEAD SYSTEMLWS1996-05-10
1619551405123025P950022TVL(TM) LEAD SYSTEMLWS1996-05-10
59351560361095P920004VASOSEAL (TM)MGB1995-09-29
1475591461275087P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMLWS1993-04-30
1619551461275087P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMLWS1993-04-30
2238281461275087P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMLWS1993-04-30
1619551346726378P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSDXY1989-08-21
1619551089540043P880006SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMMDXY1989-02-28
1619551427691137P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
1881691427691137P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
59341081502026P250022Volt™ PFA SystemQZI2025-12-19
1619551081502026P250022Volt™ PFA SystemQZI2025-12-19
1881691081502026P250022Volt™ PFA SystemQZI2025-12-19
59341847145763P220013TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency COAE2023-05-18
1619551847145763P220013TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency COAE2023-05-18
1881691847145763P220013TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency COAE2023-05-18
1881691772560416P200049Amplatzer™ Amulet™ Left Atrial Appendage OccluderNGV2021-08-14
1881691317995609P190023Portico Transcatheter Aortic Valve Implantation SystemNPT2021-09-17
59341364977690P130026TACTICATH QUARTZ SETOAE2014-10-24
1619551364977690P130026TACTICATH QUARTZ SETOAE2014-10-24
1881691364977690P130026TACTICATH QUARTZ SETOAE2014-10-24
2238281364977690P130026TACTICATH QUARTZ SETOAE2014-10-24
1619551148803325P120021AMPLATZER PFO OCCLUDERMLV2016-10-28
1881691148803325P120021AMPLATZER PFO OCCLUDERMLV2016-10-28
59341906099585P110016THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOROAD2012-01-25
59351906099585P110016THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOROAD2012-01-25
1619551906099585P110016THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOROAD2012-01-25
1881691906099585P110016THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOROAD2012-01-25
2238281906099585P110016THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOROAD2012-01-25
59341548003494P100045CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEMMOM2014-05-28
1619551548003494P100045CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEMMOM2014-05-28
1372991259362317P100029ST JUDE MEDICAL TRIFECTA VALVELWR2011-04-20
1619551259362317P100029ST JUDE MEDICAL TRIFECTA VALVELWR2011-04-20
1881691259362317P100029ST JUDE MEDICAL TRIFECTA VALVELWR2011-04-20
59341235664855P060019IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RFOAD2007-03-16
1619551235664855P060019IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RFOAD2007-03-16
1881691235664855P060019IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RFOAD2007-03-16
59341538198683P040042THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETEROAD2005-11-18
1619551538198683P040042THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETEROAD2005-11-18
1881691538198683P040042THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETEROAD2005-11-18
1881691948089994P040040AMPLATZER MUSCULAR VSD OCCLUDERMLV2007-09-07
1372991469465816P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVELWR2005-08-05
1619551469465816P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVELWR2005-08-05
59341015723031P040014IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATORLPB2005-01-14
1619551015723031P040014IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATORLPB2005-01-14
1881691015723031P040014IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATORLPB2005-01-14
1475591599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
1619551599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
2238281599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
1619551539821199P030035ANTHEM AND FRONTIER II CRT-P'SNKE2004-05-13
59351438137543P020052RESPONSE CV CATHETER SYSTEMMTE2003-05-07
1619551438137543P020052RESPONSE CV CATHETER SYSTEMMTE2003-05-07
1881691437057228P020024AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMMAE2003-05-14
1881691720702331P000039THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEMMLV2001-12-05
1619551238912569K991878LUMA-CATH STEERABLE EP CATHETERSDRF1999-12-10
1881691238912569K991878LUMA-CATH STEERABLE EP CATHETERSDRF1999-12-10
59351001682511K991486ULTRA-CBXDWZ1999-11-05
1619551001682511K991486ULTRA-CBXDWZ1999-11-05
59351533101232K984062SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229DYB1999-03-24
1619551533101232K984062SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229DYB1999-03-24
1619551716995144K982232MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEMDRF1998-07-25
1881691716995144K982232MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEMDRF1998-07-25
1619551941937867K982187FAST-CATH INTRA-CARDIAC INTRODUCERDYB1998-09-16
59351928929463K973840FAST-CATH (TM) INTRA-CARDIAC INTRODUCERDYB1998-05-21
1619551928929463K973840FAST-CATH (TM) INTRA-CARDIAC INTRODUCERDYB1998-05-21
1881691928929463K973840FAST-CATH (TM) INTRA-CARDIAC INTRODUCERDYB1998-05-21
59351018692598K964518FAST-CATH TRANSSEPTAL CATHETER INTRODUCERDYB1997-05-14
1619551018692598K964518FAST-CATH TRANSSEPTAL CATHETER INTRODUCERDYB1997-05-14
1881691018692598K964518FAST-CATH TRANSSEPTAL CATHETER INTRODUCERDYB1997-05-14
1619551519050996K961924IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEMDRF1997-04-11
1881691519050996K961924IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEMDRF1997-04-11
59351916992680K954317DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKSDYB1995-11-28
1619551916992680K954317DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKSDYB1995-11-28
1881691916992680K954317DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKSDYB1995-11-28
1475591921274733K950140IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069DTD1995-04-06
1619551368438843K946333IBI-1000(TM) ELECTROPHYSIOLOGY CATHTERDRF1995-07-18
1881691368438843K946333IBI-1000(TM) ELECTROPHYSIOLOGY CATHTERDRF1995-07-18
59351426393649K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
1619551426393649K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
1619551192343832K934285CATHETER INTRODUCER MODIFICATIONDYB1993-11-24
1475591583375331K921318ADAPTING SLEEVE KIT MODEL 4023DTD1992-08-03
1619551323538406K920779FAST-CATH HEMOSTASIS INTRODUCERDYB1992-06-03
59351463036956K920327DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCERDYB1992-04-16
1619551463036956K920327DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCERDYB1992-04-16
59351766999116K914278DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMENDRF1992-03-04
1619551766999116K914278DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMENDRF1992-03-04
1881691766999116K914278DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMENDRF1992-03-04
59351071559481K914185PACEL(TM) FLOW DIRECTED PACING CATHETERLDF1992-01-27
1619551071559481K914185PACEL(TM) FLOW DIRECTED PACING CATHETERLDF1992-01-27
1881691071559481K914185PACEL(TM) FLOW DIRECTED PACING CATHETERLDF1992-01-27
59351077458785K914138ONTRACDQX1991-12-13
1619551077458785K914138ONTRACDQX1991-12-13
59351412851232K914090DAIG FAST CATH(TM) INTRODUCER, MODIFICATIONDYB1991-10-28
1619551412851232K914090DAIG FAST CATH(TM) INTRODUCER, MODIFICATIONDYB1991-10-28
59352046220172K913940RESPONSE(TM) STEERABLE CATHETERDRA1993-01-26
1619552046220172K913940RESPONSE(TM) STEERABLE CATHETERDRA1993-01-26
1881692046220172K913940RESPONSE(TM) STEERABLE CATHETERDRA1993-01-26
1619551800861394K911883DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCERDYB1991-11-29
1619551359400925K910861PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCKDYB1991-05-07
59351900612166K910645DISPOSABLE PATIENT CABLEDSA1991-05-07
1619551900612166K910645DISPOSABLE PATIENT CABLEDSA1991-05-07
1881691900612166K910645DISPOSABLE PATIENT CABLEDSA1991-05-07
59352071295025K894500DAIG ELECTROPHYSIOLOGY CATHETERDRF1989-09-18
1619552071295025K894500DAIG ELECTROPHYSIOLOGY CATHETERDRF1989-09-18
1881692071295025K894500DAIG ELECTROPHYSIOLOGY CATHETERDRF1989-09-18
1619551602394404K894431MODIFIED LABELING TO PERMANENT LEAD INTRODUCERDYB1989-09-06
1619551769823961K894430MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAYDYB1989-08-09
59351250275189K894343DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMODYB1989-09-26
1619551250275189K894343DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMODYB1989-09-26
1881691250275189K894343DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMODYB1989-09-26
59351239843951K894330DAIG VESSEL DILATORDRE1989-09-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQK1002026-04-20
DYB982024-12-13
DRF562019-09-17
DQY352025-04-25
NQQ162016-06-29
DQX142014-11-13
GXI122025-05-27
OAD112012-01-25
MTD102024-07-09
KRH102009-10-16
GXD92022-01-21
OBJ82025-05-23
LDF82016-11-22
DXO72018-03-28
LPB72005-01-14
OWQ62023-06-30
DRC52013-02-07
LWR52011-04-20
LWS51996-05-10
MXC42023-05-17
MLV42016-10-28
OAE42014-10-24
DRG42013-12-20
KRD42012-06-12
DXC42011-02-24
JOQ42009-10-16
DRB42009-04-01
DRA42006-01-19
DSA41991-05-07
DQO32019-11-08
GEI32009-01-28
NIK32004-06-30
MOM22014-05-28
HQP22012-07-20
DXJ22011-01-26
DWZ21999-11-05
NVN21998-01-29
DTD21995-04-06
DRE21989-09-12
LWQ21982-12-17

PMA#

TactiSys Quartz Equipment

2022-12-15

St. Jude Medicalone St. Jude Medical Drivest. Paul, MN 55117 PMA NumberP130026 Supplement NumberS082 Date Received11/16/2022 Decision Date12/15/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process C...

Livewire TC Ablation Catheter

2022-12-08

St. Jude Medical14900 Minnetonka Ind Rdminnetonka, MN 55345 PMA NumberP960016 Supplement NumberS089 Date Received11/14/2022 Decision Date12/08/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Ch...

TactiCath Ablation Catheter, Sensor Enabled (SE)

2022-12-08

St. Jude Medicalone St. Jude Medical Drivest. Paul, MN 55117 PMA NumberP130026 Supplement NumberS081 Date Received11/14/2022 Decision Date12/08/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process C...

TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

2022-10-28

St. Jude Medicalone St. Jude Medical Drivest. Paul, MN 55117 PMA NumberP130026 Supplement NumberS080 Date Received09/30/2022 Decision Date10/28/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process C...

TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

2022-08-31

St. Jude Medicalone St. Jude Medical Drivest. Paul, MN 55117 PMA NumberP130026 Supplement NumberS079 Date Received08/01/2022 Decision Date08/31/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process C...

TactiSys™ Quartz Equipment

2022-04-27

St. Jude Medicalone St. Jude Medical Drivest. Paul, MN 55117 PMA NumberP130026 Supplement NumberS078 Date Received01/27/2022 Decision Date04/27/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Proce...

CardioMEMS PA Sensor and Delivery System

2022-04-11

St. Jude Medical387 Technology Circle Nwsuite 500atlanta, GA 30313 PMA NumberP100045 Supplement NumberS062 Date Received03/14/2022 Decision Date04/11/2022 Product Code MOM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...

CardioMEMS HF System

2022-03-31

St. Jude Medical387 Technology Circle Nwsuite 500atlanta, GA 30313 PMA NumberP100045 Supplement NumberS061 Date Received03/03/2022 Decision Date03/31/2022 Product Code MOM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...

CardioMEMS HF System

2022-03-04

St. Jude Medical387 Technology Circle Nwsuite 500atlanta, GA 30313 PMA NumberP100045 Supplement NumberS060 Date Received02/02/2022 Decision Date03/04/2022 Product Code MOM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...

Microny

2021-04-09

St. Jude Medical, Inc.

200 records. Showing 1-40. Next

PMN#

152 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next