Ampere™ Generator
St. Jude Medical
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012179728 | 3012179728 | St. Jude Medical | 1 | Y | 2026-01-01 | 2305 Walnut Street Roseville MN US 55113 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 188169 | 1501640764 | P960016 | LIVEWIRE(R) CARDIAC ABLATION SYSTEM | LPB | 1999-05-04 |
| 188169 | 1427691137 | P810002 | BILEAFLET-CENTER OPENING CARDIAC VALVE | LWQ | 1982-12-17 |
| 188169 | 1081502026 | P250022 | Volt™ PFA System | QZI | 2025-12-19 |
| 188169 | 1072781342 | P240042 | Tendyne Transcatheter Mitral Valve System | NPU | 2025-05-23 |
| 188169 | 1847145763 | P220013 | TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C | OAE | 2023-05-18 |
| 188169 | 1772560416 | P200049 | Amplatzer™ Amulet™ Left Atrial Appendage Occluder | NGV | 2021-08-14 |
| 188169 | 1317995609 | P190023 | Portico Transcatheter Aortic Valve Implantation System | NPT | 2021-09-17 |
| 188169 | 1364977690 | P130026 | TACTICATH QUARTZ SET | OAE | 2014-10-24 |
| 188169 | 1148803325 | P120021 | AMPLATZER PFO OCCLUDER | MLV | 2016-10-28 |
| 188169 | 1906099585 | P110016 | THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR | OAD | 2012-01-25 |
| 188169 | 1259362317 | P100029 | ST JUDE MEDICAL TRIFECTA VALVE | LWR | 2011-04-20 |
| 188169 | 1235664855 | P060019 | IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF | OAD | 2007-03-16 |
| 188169 | 1538198683 | P040042 | THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER | OAD | 2005-11-18 |
| 188169 | 1948089994 | P040040 | AMPLATZER MUSCULAR VSD OCCLUDER | MLV | 2007-09-07 |
| 188169 | 1469465816 | P040021 | SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE | LWR | 2005-08-05 |
| 188169 | 1015723031 | P040014 | IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR | LPB | 2005-01-14 |
| 188169 | 1437057228 | P020024 | AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM | MAE | 2003-05-14 |
| 188169 | 1720702331 | P000039 | THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM | MLV | 2001-12-05 |
| 188169 | 1238912569 | K991878 | LUMA-CATH STEERABLE EP CATHETERS | DRF | 1999-12-10 |
| 188169 | 1716995144 | K982232 | MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM | DRF | 1998-07-25 |
| 188169 | 1928929463 | K973840 | FAST-CATH (TM) INTRA-CARDIAC INTRODUCER | DYB | 1998-05-21 |
| 188169 | 1018692598 | K964518 | FAST-CATH TRANSSEPTAL CATHETER INTRODUCER | DYB | 1997-05-14 |
| 188169 | 1519050996 | K961924 | IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM | DRF | 1997-04-11 |
| 188169 | 1916992680 | K954317 | DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS | DYB | 1995-11-28 |
| 188169 | 1368438843 | K946333 | IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER | DRF | 1995-07-18 |
| 188169 | 1766999116 | K914278 | DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN | DRF | 1992-03-04 |
| 188169 | 1071559481 | K914185 | PACEL(TM) FLOW DIRECTED PACING CATHETER | LDF | 1992-01-27 |
| 188169 | 2046220172 | K913940 | RESPONSE(TM) STEERABLE CATHETER | DRA | 1993-01-26 |
| 188169 | 1900612166 | K910645 | DISPOSABLE PATIENT CABLE | DSA | 1991-05-07 |
| 188169 | 2071295025 | K894500 | DAIG ELECTROPHYSIOLOGY CATHETER | DRF | 1989-09-18 |
| 188169 | 1250275189 | K894343 | DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO | DYB | 1989-09-26 |
| 188169 | 1708793242 | K875059 | DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE | LDF | 1988-02-12 |
| 188169 | 1961154169 | K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | DQY | 2026-07-02 |
| 188169 | 1802099928 | K261631 | Amplatzer TorqVue Exchange System | DQY | 2026-06-17 |
| 188169 | 2051541396 | K260993 | Amplatzer TorqVue Delivery System | DQY | 2026-04-24 |
| 188169 | 1955780459 | K260499 | Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | DQY | 2026-03-13 |
| 188169 | 1292433415 | K252013 | EnSite™ X EP System | DQK | 2025-09-25 |
| 188169 | 1014675709 | K251463 | EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) | DQK | 2025-09-04 |
| 188169 | 2022175301 | K251234 | EnSite™ X EP System | DQK | 2025-07-30 |
| 188169 | 1826487014 | K251231 | ViewFlex™ X ICE Catheter, Sensor Enabled™ | OBJ | 2025-05-20 |
| 188169 | 1219462594 | K251211 | ViewFlex™ 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™ | OBJ | 2025-05-23 |
| 188169 | 1557844089 | K250426 | Amulet™ Steerable Delivery Sheath | DQY | 2025-04-25 |
| 188169 | 1701008709 | K243493 | Agilis NxT Steerable Introducer Dual-Reach | DYB | 2024-12-13 |
| 188169 | 1921629173 | K242016 | EnSite™ X EP System | DQK | 2024-08-09 |
| 188169 | 2056527922 | K241372 | Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ | MTD | 2024-07-09 |
| 188169 | 1644202159 | K241370 | Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED) | DYB | 2024-06-13 |
| 188169 | 1165671949 | K232690 | Amulet™ Steerable Delivery Sheath | DQY | 2023-09-29 |
| 188169 | 1897877020 | K231415 | EnSite™ X EP System | DQK | 2023-08-10 |
| 188169 | 1296019727 | K223077 | ViewFlex Xtra ICE Catheter | OBJ | 2022-12-07 |
| 188169 | 1469381285 | K213364 | EnSite X EP System | DQK | 2021-11-11 |
| 188169 | 1485403554 | K212738 | Amplatzer Talisman Delivery Sheath | DQY | 2021-09-27 |
| 188169 | 1055503877 | K212061 | EnSite X EP System | DQK | 2021-10-22 |
| 188169 | 1340040219 | K210392 | WorkMate Claris System | DQK | 2021-03-11 |
| 188169 | 1108038189 | K202066 | EnSite 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 Enabled | DQK | 2020-11-25 |
| 188169 | 2059853676 | K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | DQK | 2020-06-26 |
| 188169 | 1071867675 | K201148 | EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License | DQK | 2020-06-26 |
| 188169 | 1471627600 | K192037 | Advisor VL Circular Mapping Catheter, Sensor Enabled | DRF | 2019-09-17 |
| 188169 | 1299910834 | K190581 | Amplatzer Trevisio Intravascular Delivery System | DQY | 2019-04-05 |
| 188169 | 1494029169 | K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | MTD | 2018-04-23 |
| 188169 | 1813383072 | K163000 | AMPLATZER TorqVue 45x45 Delivery Sheath | DQY | 2016-12-23 |
| 188169 | 1165252743 | K162228 | TorqVue Low Profile Delivery Catheter | DQY | 2016-09-09 |
| 188169 | 1653210817 | K160878 | OPTIS Metallic Stent Optimization E.4 SW | NQQ | 2016-06-29 |
| 188169 | 1934457447 | K160335 | Advisor 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 D | DRF | 2016-12-13 |
| 188169 | 1439225457 | K152120 | OPTIS Mobile System | NQQ | 2015-10-29 |
| 188169 | 1604801522 | K151622 | St.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 Catheter | DRF | 2015-07-15 |
| 188169 | 1673010319 | K151286 | OPTIS Integrated System Mobile Workstation | NQQ | 2015-08-05 |
| 188169 | 1906216067 | K150878 | ILUMIEN OPTIS | NQQ | 2015-07-15 |
| 188169 | 1455574772 | K150631 | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter | DRF | 2015-04-01 |
| 188169 | 1034680055 | K150237 | ILUMIEN, Drageonfly OPTIS Imaging Catheter | NQQ | 2015-05-05 |
| 188169 | 1265136984 | K142254 | CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector | DQX | 2014-11-13 |
| 188169 | 1205996543 | K141769 | OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER | DQO | 2014-08-18 |
| 188169 | 1940113105 | K131063 | AMPLATZER TORQ VUE LP DELIVERY SYSTEM | DQY | 2013-08-15 |
| 188169 | 1853023659 | K130257 | CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER | DQY | 2013-03-20 |
| 188169 | 1538017994 | K130252 | CPS AIM UNIVERSAL SLITTABLE INNER CATHETER | DQY | 2013-03-20 |
| 188169 | 1771631749 | K123369 | ILUMIEN OPTIS | NQQ | 2013-01-30 |
| 188169 | 1082973445 | K120298 | CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE | DQX | 2012-05-08 |
| 188169 | 1318353310 | K113658 | AMPLATZER VASCULAR PLUG 4 | KRD | 2012-06-12 |
| 188169 | 1661648162 | K111201 | C7 XR IMAGING SYSTEM | NQQ | 2011-08-10 |
| 188169 | 1019140892 | K110450 | AGILIS NXT STEERABLE INTRODUCER | DYB | 2011-05-10 |
| 188169 | 2071779779 | K110193 | FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F | DXC | 2011-02-24 |
| 188169 | 1320672112 | K103250 | CPS DIRECT SL II SLITTABLE OUTER CATHETER | DQY | 2011-01-19 |
| 188169 | 1994580079 | K101955 | ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058 | DRF | 2010-10-15 |
| 188169 | 1467212785 | K101623 | INQUIRY AFOCUSII DIAGNOSTIC CATHETER | DRF | 2010-08-13 |
| 188169 | 1213793817 | K093857 | C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES | NQQ | 2010-04-30 |
| 188169 | 1077668652 | K093476 | AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 | DQY | 2010-02-05 |
| 188169 | 1062733257 | K092913 | EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 | JOQ | 2009-10-16 |
| 188169 | 1929074796 | K092876 | SJM ATTUNE ANNULOPLASTY RING | KRH | 2009-10-16 |
| 188169 | 1199843655 | K092310 | SEGUIN ANNULOPLASTY RING | KRH | 2009-08-27 |
| 188169 | 1375790091 | K092075 | CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 | DQY | 2009-08-07 |
| 188169 | 1122749470 | K090613 | CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 | DQY | 2009-07-01 |
| 188169 | 1577573083 | K083083 | AGILIS NXT STEERABLE INTRODUCER | DYB | 2008-11-06 |
| 188169 | 1928361996 | K082932 | CPS AIM SL SLITTABLE INNER CATHETER | DQY | 2008-12-12 |
| 188169 | 1267143455 | K081645 | AGILIS NXT STEERABLE INTRODUCER, MODEL G408324 | DYB | 2008-12-09 |
| 188169 | 1712120060 | K080994 | AMPLATZER TORQVUE EXCHANGE SYSTEM | DQY | 2008-05-16 |
| 188169 | 1271367994 | K080179 | REFLEXION HD HIGH-DENSITY MAPPING CATHETER | DRF | 2009-01-07 |
| 188169 | 1731526862 | K072313 | AMPLATZER TORQVUE DELIVERY SYSTEM | DQY | 2007-11-02 |
| 188169 | 1781784608 | K072278 | BRK TRANSSEPTAL NEEDLE | DRC | 2007-09-13 |
| 188169 | 1081802201 | K072012 | REFLEXION SPIRAL VARIABLE RADIUS CATHETER | DRF | 2007-08-22 |
| 188169 | 1059435710 | K071699 | AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 | KRD | 2007-08-15 |
| 188169 | 1809836289 | K071125 | AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 | KRD | 2007-06-18 |
| 188169 | 1815161517 | K062251 | REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804 | DRF | 2006-10-20 |
| 188169 | 1442015302 | K061363 | AGILIS NXT STEERABLE INTRODUCER | DYB | 2006-07-12 |
| 188169 | 1588701191 | K061015 | FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER | DYB | 2006-08-03 |
| 188169 | 1633340015 | K060757 | INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER | DRF | 2006-04-19 |
| 188169 | 1989094675 | K053440 | AMPLATZER SIZING BALLOON II | MJN | 2005-12-30 |
| 188169 | 1382308968 | K053277 | CPS DIRECT SL OUTER CATHETER | DQY | 2006-02-24 |
| 188169 | 1680841013 | K052644 | SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER | DYB | 2005-12-05 |
| 188169 | 1614043964 | K042775 | INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER | DRF | 2004-11-04 |
| 188169 | 1061669529 | K042734 | SJM RIGID SADDLE RING MODEL RSAR-(SIZE) | KRH | 2004-12-17 |
| 188169 | 2068104136 | K031810 | AMPLATZER VASCULAR PLUG | KRD | 2003-09-09 |
| 188169 | 1035816328 | K024107 | FEMOSTOP FEMORAL COMPRESSION SYSTEM | DXC | 2002-12-24 |
| 188169 | 1653548165 | K022380 | LIVESIRE ELECTROPHYSIOLOGY CATHETER | DRF | 2002-10-01 |
| 188169 | 1074715955 | K022363 | SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND) | KRH | 2002-09-19 |
| 188169 | 1771919448 | K014161 | SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) | KRH | 2002-01-15 |
| 188169 | 1119662764 | K010471 | AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 | DRF | 2001-06-06 |
| 188169 | 1279944920 | K002976 | RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX | DRF | 2000-12-22 |
| 188169 | 1038117842 | ||||
| 188169 | 1156644840 | ||||
| 188169 | 1244226634 | ||||
| 188169 | 1303377489 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DQY | 21 | 2026-07-02 |
| DRF | 20 | 2019-09-17 |
| DYB | 12 | 2024-12-13 |
| DQK | 11 | 2025-09-25 |
| NQQ | 8 | 2016-06-29 |
| KRH | 5 | 2009-10-16 |
| KRD | 4 | 2012-06-12 |
| OBJ | 3 | 2025-05-23 |
| MLV | 3 | 2016-10-28 |
| OAD | 3 | 2012-01-25 |
| MTD | 2 | 2024-07-09 |
| DQX | 2 | 2014-11-13 |
| LWR | 2 | 2011-04-20 |
| DXC | 2 | 2011-02-24 |
| LPB | 2 | 2005-01-14 |
| LDF | 2 | 1992-01-27 |
| NPT | 1 | 2021-09-17 |
| NGV | 1 | 2021-08-14 |
| OAE | 1 | 2014-10-24 |
| DQO | 1 | 2014-08-18 |
| JOQ | 1 | 2009-10-16 |
| DRC | 1 | 2007-09-13 |
| MJN | 1 | 2005-12-30 |
| MAE | 1 | 2003-05-14 |
| DRA | 1 | 1993-01-26 |
| DSA | 1 | 1991-05-07 |
| LWQ | 1 | 1982-12-17 |
St. Jude Medical
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