| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Protecta ICD, Prote (P980016/S650) | Medtronic Cardiac Rhythm Disease Management | 2017-12-14 |
| Micra TPS (P150033/S028) | Medtronic, Inc. | 2017-12-14 |
| Myocardial Pacing Lead (P120017/S011) | Medtronic, Inc. | 2017-12-14 |
| SelectSecure Lead (P030036/S097) | Medtronic Cardiac Rhythm Disease Management | 2017-12-14 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S129) | Medtronic Cardiac Rhythm Disease Management | 2017-12-14 |
| Epic Vascular Self-Expanding Stent System (P110035/S044) | Boston Scientific Corp | 2017-12-14 |
| Innova Self-Expanding Stent System (P140028/S030) | Boston Scientific Corporation | 2017-12-14 |
| Transvene CS/SVC Lead (P980050/S113) | Medtronic, Inc. | 2017-12-14 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S348) | Medtronic, Inc. | 2017-12-14 |
| Attain StarFix Lead (P060039/S082) | Medtronic, Inc. | 2017-12-14 |
| Melody TPV System (P140017/S010) | Medtronic, Inc. | 2017-12-14 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S069) | Medtronic Cryocath, LP | 2017-12-14 |
| CapSureFix MRI Lead, Revo MRI SureScan IPG (P090013/S267) | Medtronic, Inc. | 2017-12-14 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S152) | Medtronic Cardiac Rhythm Disease Management | 2017-12-14 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra XT DR MRI IPG, Astra S DR MRI IPG, (P980035/S528) | Medtronic, Inc. | 2017-12-14 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S035) | Boston Scientific Corporation | 2017-12-14 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active, Fixation Lead (P930039/S178) | Medtronic, Inc. | 2017-12-14 |
| CapSure VDD 2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S383) | Medtronic, Inc. | 2017-12-14 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S611) | Medtronic Cardiac Rhythm Disease Management | 2017-12-14 |
| Gore Tigris Vascular Stent (P160004/S007) | W. L. Gore & Associates, Inc. | 2017-12-13 |
| Impella RP System (P170011/S001) | Abiomed, Inc. | 2017-12-13 |
| Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant (P010012/S465) | Boston Scientific Corp | 2017-12-13 |
| Latitude NXT Patient Management System, Wave Communicator, G2 Communicator, Consult Communicator, NXT System Server Soft (P910077/S162) | Boston Scientific | 2017-12-13 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S099) | Abbott Vascular, Inc. | 2017-12-13 |
| Revo MRI SureScan IPG (P090013/S268) | Medtronic, Inc. | 2017-12-13 |
| Hancock II Bioprosthesis & Hancock Ultra II Bisprosthesis (P980043/S062) | Medtronic, Inc. | 2017-12-13 |
| Open Pivot Heart Valve / Aortic Valved Graft (P990046/S050) | Medtronic Ats Medical, Inc. | 2017-12-13 |
| Emblem (P110042/S092) | Boston Scientific Corporation | 2017-12-13 |
| Hancock Valved Conduiis (P870078/S037) | Medtronic, Inc. | 2017-12-13 |
| Evera MRI ICD,Evera S DR ICD,Evera MRI DF-1 ICD,Evera S VR ICD,Evera XT DR ICD, Evera XT VR ICD,Protecta ICD, Protecta V (P980016/S651) | Medtronic Cardiac Rhythm Disease Management | 2017-12-13 |
| Mosaic Bioprosthesis & Ultra Bioprosthesis (P990064/S070) | Medtronic, Inc. | 2017-12-13 |
| Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant, Pervica (P960040/S406) | Boston Scientific | 2017-12-13 |
| IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S043) | Boston Scientific | 2017-12-13 |
| Gore Viabahn Endoprosthesis (P040037/S107) | W. L. Gore & Associates, Inc. | 2017-12-13 |
| Adapta,Versa,Sensia IPG, Adapta,Versa,Sensia IPG,Advisa DR IPG, Advisa DR MRI IPG,Advisa SR MRI IPG,Relia IPG (P980035/S529) | Medtronic, Inc. | 2017-12-13 |
| Gore Excluder AAA Endoprosthesis (P020004/S149) | W. L. Gore & Associates, Inc. | 2017-12-13 |
| Freestyle Bioprosthesis (P970031/S058) | Medtronic, Inc. | 2017-12-13 |
| Invive, Intua, Visionist, Valitude (P030005/S161) | Guidant Corp. | 2017-12-13 |
| Hancock Modified Orifice Valved Conduit (P790007/S052) | Medtronic Heart Valves | 2017-12-13 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D,Claria MRI Quad CRT-D, Compia M (P010031/S612) | Medtronic Cardiac Rhythm Disease Management | 2017-12-13 |
| Advantio, Ingenio, Vitalio, formio, Essentio, Accolade, Proponent, Insignia, Altrua 2 (N970003/S213) | Boston Scientific Corp | 2017-12-13 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S349) | Medtronic, Inc. | 2017-12-13 |
| Gore Viabahn Endoprosthesis with Heparin Bioactive Surface (P130006/S046) | W. L. Gore & Associates, Inc. | 2017-12-13 |
| Gore Tag Thoracic Endoprosthesis (P040043/S097) | W. L. Gore & Associates, Inc. | 2017-12-13 |
| PSW 1704.U (P070008/S087) | Biotronik, Inc. | 2017-12-12 |
| Core Valve Evolut R System and Core Valve Evolut PRO System (P130021/S048) | Medtronic, Inc. | 2017-12-12 |
| PSW 1704.U (P950037/S182) | Biotronik, Inc. | 2017-12-12 |
| WCD 4000 LifeVest Wearable Defibrillator (P010030/S103) | Zoll Manufacturing Corporation | 2017-12-12 |
| Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD; Visia AF MRI DF1 IC (P980016/S648) | Medtronic Cardiac Rhythm Disease Management | 2017-12-12 |
| Tendril MRI Leads (P140033/S014) | ABBOTT MEDICAL | 2017-12-12 |
| PSW 1704.U (P050023/S113) | Biotronik, Inc. | 2017-12-12 |
| Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Compia (P010031/S609) | Medtronic Cardiac Rhythm Disease Management | 2017-12-12 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S150) | Boston Scientific Corp | 2017-12-12 |
| PSW 1704.U (P000009/S075) | Biotronik, Inc. | 2017-12-12 |
| Unify/ Unify Quadra/ Unify Assura/ Quadra Assura/ Quadra Assura MP (P030054/S342) | ABBOTT MEDICAL | 2017-12-11 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Protecta ICD, Prote (P980016/S647) | Medtronic Cardiac Rhythm Disease Management | 2017-12-11 |
| Accolade Non-MRI Pacemakers: ALTRUA 2, ESSENTIO, PROPONENT and ACCOLADE (N970003/S219) | Boston Scientific Corp | 2017-12-11 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S608) | Medtronic Cardiac Rhythm Disease Management | 2017-12-11 |
| NG3 Implantable Cardiac Defibrillators (ICDs): AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 ICDs: MOMENTUM, VIGILANT, PERCIV (P960040/S410) | Boston Scientific | 2017-12-11 |
| NG3 Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Devices: AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 CRT-D Devi (P010012/S469) | Boston Scientific Corp | 2017-12-11 |
| Revo MRI SureScan IPG (P090013/S266) | Medtronic, Inc. | 2017-12-11 |
| Fortify; Fortify Assura (P910023/S398) | ABBOTT MEDICAL | 2017-12-11 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra XT DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra (P980035/S526) | Medtronic, Inc. | 2017-12-11 |
| Consulta CRT-P, Percepta Bipolar CRT-P,Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solar (P010015/S347) | Medtronic, Inc. | 2017-12-11 |
| CoreValve Evolut R System and CoreValve Evolut Pro System (P130021/S047) | Medtronic, Inc. | 2017-12-11 |
| Accolade Cardiac Resynchronization Therapy-Pacemaker (CRT-P) Devices: VALITUDE, VALITUDE, and VISIONIST (P030005/S167) | Guidant Corp. | 2017-12-11 |
| Accolade MRI Pacemakers: ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI (P150012/S046) | Boston Scientific | 2017-12-11 |
| Final Crimp Stopper (P140031/S058) | Edwards Lifesciences, LLC | 2017-12-11 |
| Sapien 3 Transcatheter Heart Valve (P140031/S057) | Edwards Lifesciences, LLC | 2017-12-11 |
| EDWARDS INTUITY ELITE Valve System (P150036/S021) | Edwards Lifesciences, LLC | 2017-12-08 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S171) | Edwards Lifesciences, LLC | 2017-12-08 |
| Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve (P150048/S010) | Edwards Lifesciences, LLC | 2017-12-08 |
| RelayPlus Thoracic Stent-Graft System (P110038/S016) | Bolton Medical, Inc. | 2017-12-08 |
| SynCardia temporary Total Artificial Heart (TAH-t) System / Companion 2 Driver System (P030011/S057) | Syncardia Systems, LLC | 2017-12-08 |
| Fortify Assura , Ellipse (P910023/S397) | ABBOTT MEDICAL | 2017-12-07 |
| Unify/ Unify Quadra/ Unify Assura / Quadra Assura MP (P030054/S341) | ABBOTT MEDICAL | 2017-12-07 |
| Tendril MRI (P140033/S020) | ABBOTT MEDICAL | 2017-12-07 |
| Tendril ST; Tendril STS; Optisense (P960013/S093) | ABBOTT MEDICAL | 2017-12-07 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S059) | Syncardia Systems, LLC | 2017-12-07 |
| ALTRUA 2, ESSONTIO, PROPONENT, ACCOLADE, ADVANTIO, INGENIO, VITALIO, Non-MRI Pacemakers (N970003/S220) | Boston Scientific Corp | 2017-12-06 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI, MRI Pacemakers (P150012/S048) | Boston Scientific | 2017-12-06 |
| ESSENTIO MRI / PROPONENT MRI /ACCOLADE MRI / Accolade MRI Pacemakers (P150012/S049) | Boston Scientific | 2017-12-06 |
| ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, RESONATE, PERCIVA, PUNCTUA, ENERGEN, INCEPTA , Inplantable Cardiov (P960040/S411) | Boston Scientific | 2017-12-06 |
| ORIGEN / INOGEN / DYNAGEN / AUTOGEN / MOMENTUM / VIGILANT / RESONATE / Implantable Cardiac Resynchronization Therapy Def (P010012/S471) | Boston Scientific Corp | 2017-12-06 |
| SynCardia temporary Total Artificial Heart (TAH-T) System (P030011/S050) | Syncardia Systems, LLC | 2017-12-06 |
| VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4, INVIVE, INTUA Cardiac Resynchronization Therapy-Pacemaler (CRT-P) (P030005/S168) | Guidant Corp. | 2017-12-06 |
| ALTRUA 2 / ESSENTIO / PROPONENT / ACCOLADE / Accolade Non-MRI Pacemakers (N970003/S221) | Boston Scientific Corp | 2017-12-06 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S007) | Medtronic Vascular | 2017-12-06 |
| EMBLEM SICD GEN 2, SICD EMBLEM MRI , Subcutaneous Implantable Cardioverter Defibrillator (SICD) (P110042/S097) | Boston Scientific Corporation | 2017-12-06 |
| ORIGEN / INOGEN / DYNAGEN /AUTOGEN /MOMENTUM /VIGILANT/ PERCIVA / RESONATE/ Implantable Cardioverter Defibrillator (ICD) (P960040/S413) | Boston Scientific | 2017-12-06 |
| ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, RESONATE, PERCIVA, PUNCTUA, ENERGEN, INCEPTA , Cardiac Resynchroni (P010012/S470) | Boston Scientific Corp | 2017-12-06 |
| VALITUDE / VALITUDE X4 / VISIONIST / VISIONIST X4 / Accolade C ardiac Resynchronization Therapy-Pacemaker (CRT-P) Device (P030005/S169) | Guidant Corp. | 2017-12-06 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S346) | Medtronic, Inc. | 2017-12-05 |
| Revo MRI SureScan IPG (P090013/S265) | Medtronic, Inc. | 2017-12-05 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Pro (P980016/S646) | Medtronic Cardiac Rhythm Disease Management | 2017-12-05 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S016) | Boston Scientific Corp | 2017-12-05 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra XT DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra (P980035/S525) | Medtronic, Inc. | 2017-12-05 |
| ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA (P000037/S050) | On-X Life Technologies, Inc. | 2017-12-05 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S607) | Medtronic Cardiac Rhythm Disease Management | 2017-12-05 |
| Adapta, Versa, Sensia IPG/Attesta IPG/Relia IPG/Sphera IPG (P980035/S527) | Medtronic, Inc. | 2017-12-04 |