St. Jude Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30121797283012179728St. Jude Medical1Y2026-01-012305 Walnut Street Roseville MN US 55113

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1881691501640764P960016LIVEWIRE(R) CARDIAC ABLATION SYSTEMLPB1999-05-04
1881691427691137P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
1881691081502026P250022Volt™ PFA SystemQZI2025-12-19
1881691072781342P240042Tendyne Transcatheter Mitral Valve SystemNPU2025-05-23
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
1881691364977690P130026TACTICATH QUARTZ SETOAE2014-10-24
1881691148803325P120021AMPLATZER PFO OCCLUDERMLV2016-10-28
1881691906099585P110016THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOROAD2012-01-25
1881691259362317P100029ST JUDE MEDICAL TRIFECTA VALVELWR2011-04-20
1881691235664855P060019IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RFOAD2007-03-16
1881691538198683P040042THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETEROAD2005-11-18
1881691948089994P040040AMPLATZER MUSCULAR VSD OCCLUDERMLV2007-09-07
1881691469465816P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVELWR2005-08-05
1881691015723031P040014IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATORLPB2005-01-14
1881691437057228P020024AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMMAE2003-05-14
1881691720702331P000039THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEMMLV2001-12-05
1881691238912569K991878LUMA-CATH STEERABLE EP CATHETERSDRF1999-12-10
1881691716995144K982232MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEMDRF1998-07-25
1881691928929463K973840FAST-CATH (TM) INTRA-CARDIAC INTRODUCERDYB1998-05-21
1881691018692598K964518FAST-CATH TRANSSEPTAL CATHETER INTRODUCERDYB1997-05-14
1881691519050996K961924IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEMDRF1997-04-11
1881691916992680K954317DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKSDYB1995-11-28
1881691368438843K946333IBI-1000(TM) ELECTROPHYSIOLOGY CATHTERDRF1995-07-18
1881691766999116K914278DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMENDRF1992-03-04
1881691071559481K914185PACEL(TM) FLOW DIRECTED PACING CATHETERLDF1992-01-27
1881692046220172K913940RESPONSE(TM) STEERABLE CATHETERDRA1993-01-26
1881691900612166K910645DISPOSABLE PATIENT CABLEDSA1991-05-07
1881692071295025K894500DAIG ELECTROPHYSIOLOGY CATHETERDRF1989-09-18
1881691250275189K894343DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMODYB1989-09-26
1881691708793242K875059DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODELDF1988-02-12
1881691961154169K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQY2026-07-02
1881691802099928K261631Amplatzer TorqVue Exchange SystemDQY2026-06-17
1881692051541396K260993Amplatzer TorqVue Delivery SystemDQY2026-04-24
1881691955780459K260499Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80DQY2026-03-13
1881691292433415K252013EnSite™ X EP SystemDQK2025-09-25
1881691014675709K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)DQK2025-09-04
1881692022175301K251234EnSite™ X EP SystemDQK2025-07-30
1881691826487014K251231ViewFlex™ X ICE Catheter, Sensor Enabled™OBJ2025-05-20
1881691219462594K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™OBJ2025-05-23
1881691557844089K250426Amulet™ Steerable Delivery SheathDQY2025-04-25
1881691701008709K243493Agilis NxT Steerable Introducer Dual-ReachDYB2024-12-13
1881691921629173K242016EnSite™ X EP SystemDQK2024-08-09
1881692056527922K241372Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™MTD2024-07-09
1881691644202159K241370Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)DYB2024-06-13
1881691165671949K232690Amulet™ Steerable Delivery SheathDQY2023-09-29
1881691897877020K231415EnSite™ X EP SystemDQK2023-08-10
1881691296019727K223077ViewFlex Xtra ICE CatheterOBJ2022-12-07
1881691469381285K213364EnSite X EP SystemDQK2021-11-11
1881691485403554K212738Amplatzer Talisman Delivery SheathDQY2021-09-27
1881691055503877K212061EnSite X EP SystemDQK2021-10-22
1881691340040219K210392WorkMate Claris SystemDQK2021-03-11
1881691108038189K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor EnabledDQK2020-11-25
1881692059853676K201181EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping SystemDQK2020-06-26
1881691071867675K201148EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software LicenseDQK2020-06-26
1881691471627600K192037Advisor VL Circular Mapping Catheter, Sensor EnabledDRF2019-09-17
1881691299910834K190581Amplatzer Trevisio Intravascular Delivery SystemDQY2019-04-05
1881691494029169K172393Advisor HD Grid Mapping Catheter, Sensor EnabledMTD2018-04-23
1881691813383072K163000AMPLATZER TorqVue 45x45 Delivery SheathDQY2016-12-23
1881691165252743K162228TorqVue Low Profile Delivery CatheterDQY2016-09-09
1881691653210817K160878OPTIS Metallic Stent Optimization E.4 SWNQQ2016-06-29
1881691934457447K160335Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi DDRF2016-12-13
1881691439225457K152120OPTIS Mobile SystemNQQ2015-10-29
1881691604801522K151622St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology CatheterDRF2015-07-15
1881691673010319K151286OPTIS Integrated System Mobile WorkstationNQQ2015-08-05
1881691906216067K150878ILUMIEN OPTISNQQ2015-07-15
1881691455574772K150631St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology CatheterDRF2015-04-01
1881691034680055K150237ILUMIEN, Drageonfly OPTIS Imaging CatheterNQQ2015-05-05
1881691265136984K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire ConnectorDQX2014-11-13
1881691205996543K141769OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETERDQO2014-08-18
1881691940113105K131063AMPLATZER TORQ VUE LP DELIVERY SYSTEMDQY2013-08-15
1881691853023659K130257CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETERDQY2013-03-20
1881691538017994K130252CPS AIM UNIVERSAL SLITTABLE INNER CATHETERDQY2013-03-20
1881691771631749K123369ILUMIEN OPTISNQQ2013-01-30
1881691082973445K120298CPS EXCEL MEDIGUIDE ENABLED GUIDEWIREDQX2012-05-08
1881691318353310K113658AMPLATZER VASCULAR PLUG 4KRD2012-06-12
1881691661648162K111201C7 XR IMAGING SYSTEMNQQ2011-08-10
1881691019140892K110450AGILIS NXT STEERABLE INTRODUCERDYB2011-05-10
1881692071779779K110193FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; FDXC2011-02-24
1881691320672112K103250CPS DIRECT SL II SLITTABLE OUTER CATHETERDQY2011-01-19
1881691994580079K101955ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058DRF2010-10-15
1881691467212785K101623INQUIRY AFOCUSII DIAGNOSTIC CATHETERDRF2010-08-13
1881691213793817K093857C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIESNQQ2010-04-30
1881691077668652K093476AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120DQY2010-02-05
1881691062733257K092913EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04JOQ2009-10-16
1881691929074796K092876SJM ATTUNE ANNULOPLASTY RINGKRH2009-10-16
1881691199843655K092310SEGUIN ANNULOPLASTY RINGKRH2009-08-27
1881691375790091K092075CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005DQY2009-08-07
1881691122749470K090613CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2DQY2009-07-01
1881691577573083K083083AGILIS NXT STEERABLE INTRODUCERDYB2008-11-06
1881691928361996K082932CPS AIM SL SLITTABLE INNER CATHETERDQY2008-12-12
1881691267143455K081645AGILIS NXT STEERABLE INTRODUCER, MODEL G408324DYB2008-12-09
1881691712120060K080994AMPLATZER TORQVUE EXCHANGE SYSTEMDQY2008-05-16
1881691271367994K080179REFLEXION HD HIGH-DENSITY MAPPING CATHETERDRF2009-01-07
1881691731526862K072313AMPLATZER TORQVUE DELIVERY SYSTEMDQY2007-11-02
1881691781784608K072278BRK TRANSSEPTAL NEEDLEDRC2007-09-13
1881691081802201K072012REFLEXION SPIRAL VARIABLE RADIUS CATHETERDRF2007-08-22
1881691059435710K071699AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022KRD2007-08-15
1881691809836289K071125AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016KRD2007-06-18
1881691815161517K062251REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804DRF2006-10-20
1881691442015302K061363AGILIS NXT STEERABLE INTRODUCERDYB2006-07-12
1881691588701191K061015FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCERDYB2006-08-03
1881691633340015K060757INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETERDRF2006-04-19
1881691989094675K053440AMPLATZER SIZING BALLOON IIMJN2005-12-30
1881691382308968K053277CPS DIRECT SL OUTER CATHETERDQY2006-02-24
1881691680841013K052644SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCERDYB2005-12-05
1881691614043964K042775INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETERDRF2004-11-04
1881691061669529K042734SJM RIGID SADDLE RING MODEL RSAR-(SIZE)KRH2004-12-17
1881692068104136K031810AMPLATZER VASCULAR PLUGKRD2003-09-09
1881691035816328K024107FEMOSTOP FEMORAL COMPRESSION SYSTEMDXC2002-12-24
1881691653548165K022380LIVESIRE ELECTROPHYSIOLOGY CATHETERDRF2002-10-01
1881691074715955K022363SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)KRH2002-09-19
1881691771919448K014161SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)KRH2002-01-15
1881691119662764K010471AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569DRF2001-06-06
1881691279944920K002976RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXXDRF2000-12-22
1881691038117842
1881691156644840
1881691244226634
1881691303377489

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQY212026-07-02
DRF202019-09-17
DYB122024-12-13
DQK112025-09-25
NQQ82016-06-29
KRH52009-10-16
KRD42012-06-12
OBJ32025-05-23
MLV32016-10-28
OAD32012-01-25
MTD22024-07-09
DQX22014-11-13
LWR22011-04-20
DXC22011-02-24
LPB22005-01-14
LDF21992-01-27
NPT 12021-09-17
NGV 12021-08-14
OAE12014-10-24
DQO12014-08-18
JOQ12009-10-16
DRC12007-09-13
MJN12005-12-30
MAE12003-05-14
DRA11993-01-26
DSA11991-05-07
LWQ11982-12-17

PMA#

200 records. Showing 1-40. Next

PMN#

100 records. Showing 1-40. Next