| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S043) | ABBOTT MEDICAL | 2017-05-22 |
| MELODY TRANSCATHETER PULMONARY VALVE , ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) (P140017/S006) | Medtronic, Inc. | 2017-05-22 |
| Therapy Cool Path Duo Ablation Catheter, Therapy Cool Flex Ablation Catheter, Therapy Cool Path Duo SP Ablation Catheter (P110016/S046) | ABBOTT MEDICAL | 2017-05-19 |
| Ingevity Lead Manufacturing Changes (P150012/S029) | Boston Scientific | 2017-05-19 |
| Melody Transcatheter Pulmonary Valve System (P140017/S007) | Medtronic, Inc. | 2017-05-19 |
| Therapy Dual-8 Ablation Catheter, Therapy 8mm Thermistor Ablation Catheter, Safire TX Ablation Catheter (P040042/S037) | Irvine Biomedical,Inc.(Ibi) | 2017-05-19 |
| Model A219 EMBLEM MRI S-ICD Pulse Generator; Model A209 EMBLEM S-ICD Pulse Generator; Model 2877 Programmer Software App (P110042/S080) | Boston Scientific Corporation | 2017-05-19 |
| Therapy Cool Path Ablation Catheters, Therapy Cool Path SP Ablation Catheter and Safire BLU SP Ablation Catheter (P060019/S039) | Irvine Biomedical, Inc. | 2017-05-19 |
| Angio Seal Vascular Closure Device (P930038/S083) | Terumo Medical Corporation | 2017-05-19 |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S019) | ABBOTT MEDICAL | 2017-05-19 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant FreeFlo Tapered Stent Graft Configurations (P100040/S031) | Medtronic Vascular | 2017-05-19 |
| Stent Graft Drying Process at Medtronic Empalme And Medtronic Tijuana Endurant, Endurant II, Endurant II Aorto-Uni-lliac (P100021/S064) | Medtronic Vascular | 2017-05-19 |
| PreveLeak Surgical Sealant & 10pk applictor tips (P100030/S005) | Baxter Healthcare Corporation | 2017-05-19 |
| Livewire TC Ablation Catheter and Safire Bi-Directional Ablation Catheter (P960016/S068) | St Jude Medical | 2017-05-19 |
| Therapy Ablation Catheter including Bi-Directional catheter and Therapy 4mm Thermistor Ablation Catheter (P040014/S032) | Irvine Biomedical, Inc. | 2017-05-19 |
| Cardiac Resynchronization Therapy Defibrillator; Dynagen, Inogen, Origen, Autogen CRT-D's (P010012/S446) | Boston Scientific Corp | 2017-05-18 |
| Implantable Cardioverter Defibrilllator/ Dynagen, Inogen, Origen and Autogen ICD's. (P960040/S390) | Boston Scientific | 2017-05-18 |
| Medtronic CoreValve(TM) Evolut (TM) R System (P130021/S031) | Medtronic, Inc. | 2017-05-16 |
| Amplia, Brava, Claria, Compia, Consulta, Maximo, Protecta, Viva Quad MRI CRT-D (P010031/S592) | Medtronic Cardiac Rhythm Disease Management | 2017-05-15 |
| Evera, Maximo, Protecta, Secura, Visia MRI VR/XT/DR/AF ICD (P980016/S631) | Medtronic Cardiac Rhythm Disease Management | 2017-05-15 |
| Express SD Monorail® Premounted Stent System (P060006/S082) | Boston Scientific Corp | 2017-05-12 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S019) | Boston Scientific Corp | 2017-05-12 |
| PROMUS Element Plus Everolimus-Eiuting Stent System (P110010/S141) | Boston Scientific Corp | 2017-05-12 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S089) | Medtronic | 2017-05-12 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S039) | Boston Scientific Corp | 2017-05-12 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S073) | Boston Scientific Corp | 2017-05-12 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S100) | Boston Scientific | 2017-05-12 |
| Blazer II TM Cardiac Ablation Catheter and Cable (P920047/S097) | Boston Scientific Corp | 2017-05-12 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S054) | Syncardia Systems, LLC | 2017-05-12 |
| Rotablator® Rotational Atherectomy System (P900056/S160) | Boston Scientific Corp | 2017-05-12 |
| MITRACLIP NT CLIP DELIVER SYSTEM (P100009/S021) | ABBOTT MEDICAL | 2017-05-11 |
| Epic Vascular Self-Expanding Stent System (P110035/S039) | Boston Scientific Corp | 2017-05-10 |
| Spectranetics Laser Sheth (SLS) II, Glidel Light Laser Sheath (P960042/S057) | Spectranetics (Philips) | 2017-05-10 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S038) | Edwards Lifesciences, LLC | 2017-05-10 |
| Express SD Renal Stent System (P060006/S081) | Boston Scientific Corp | 2017-05-10 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S140) | Boston Scientific Corp | 2017-05-10 |
| Rebel Platinum Chromium Coronary Stent System Monorail and Over The Wire (P130030/S038) | Boston Scientific Corp | 2017-05-10 |
| EDWARDS INTUITY Valve System (P150036/S007) | Edwards Lifesciences, LLC | 2017-05-10 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S073) | Edwards Lifesciences, LLC | 2017-05-10 |
| Wolverine Coronary Cutting Balloon (P950020/S080) | Boston Scientific Corp | 2017-05-10 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis (P860057/S159) | Edwards Lifesciences, LLC | 2017-05-10 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S029) | Boston Scientific Corporation | 2017-05-10 |
| Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System (P150023/S008) | Abbott Vascular, Inc. | 2017-05-09 |
| Medtronic CoreValve System (P130021/S034) | Medtronic, Inc. | 2017-05-09 |
| IN.PACT Admiral Paclitaxel-Coated Balloon Catheter (P140010/S031) | Medtronic, Inc. | 2017-05-08 |
| IntellaNav Ol (P150005/S015) | Boston Scientific Corp | 2017-05-08 |
| IntellaNav XP, Nav MiFi XP (P020025/S096) | Boston Scientific | 2017-05-08 |
| Pacemaker ICD CRT Non Implanted components. (P000009/S071) | Biotronik, Inc. | 2017-05-06 |
| CAPSUREFIX NOVUS MRI SURESCAN LEAD (P930039/S166) | Medtronic, Inc. | 2017-05-06 |
| Edora / Enitra /Enticos / Evity PSW 1701.U (P950037/S175) | Biotronik, Inc. | 2017-05-06 |
| PERCEPTA QUAD CRT-P MRI SURESCAN, SERENA QUAD CRT-P MRI SURESCAN, SOLARA QUAD CRT-P MRI SURESCAN, IMPLANTABLE PULSE GENE (P010015/S317) | Medtronic, Inc. | 2017-05-06 |
| SELECTSECURE LEAD MODEL 3830 (P030036/S091) | Medtronic Cardiac Rhythm Disease Management | 2017-05-06 |
| Defibrillator, Implantable, Dual Chamber, Automatic Implantable Cardioverter with Cardiac Resynchronization (P050023/S107) | Biotronik, Inc. | 2017-05-06 |
| Eluna / Epyra / Etrinsa (P070008/S082) | Biotronik, Inc. | 2017-05-06 |
| MODEL 6725 IS-1 PIN PLUG (P920015/S191) | Medtronic, Inc. | 2017-05-06 |
| CAPSUREFIX NOVUS MRI SURESCAN LEAD (P930039/S165) | Medtronic, Inc. | 2017-05-06 |
| Lumos DR-T/VR-T (P000009/S072) | Biotronik, Inc. | 2017-05-06 |
| CAPSURE SENSE MRI SURESCAN LEAD (P830061/S141) | Medtronic Cardiac Rhythm Disease Management | 2017-05-06 |
| SELECTSECURE MRI SURESCAN LEAD (P030036/S092) | Medtronic Cardiac Rhythm Disease Management | 2017-05-06 |
| CAPSUREFIX MRI SURESCAN LEAD (P090013/S244) | Medtronic, Inc. | 2017-05-06 |
| ASTRA XT SR MRI SURESCAN, ASTRA XT DR MRI SURESCAN, ASTRA S SR MRI SURESCAN, ASTRA S DR MRI SURESCAN, SOFTWARE MODEL (P980035/S486) | Medtronic, Inc. | 2017-05-06 |
| CAPSUREFIX MRI SURESCAN LEAD (P090013/S245) | Medtronic, Inc. | 2017-05-06 |
| Inventra / Iperia / Itrevia (P050023/S108) | Biotronik, Inc. | 2017-05-06 |
| Pulse Generator, Permanent Implantable (P950037/S173) | Biotronik, Inc. | 2017-05-06 |
| MEDTRONIC ATTAIN ABILITY MRI SURESCAN, ATTAIN PERFORMA MRI SURESCAN LEAD (P080006/S105) | Medtronic, Inc. | 2017-05-06 |
| CAPSURE SENSE MRI SURESCAN LEAD (P830061/S140) | Medtronic Cardiac Rhythm Disease Management | 2017-05-06 |
| Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software (P140033/S007) | ABBOTT MEDICAL | 2017-05-05 |
| Cadence(R) Tiered Therapy Defribilation System (P910023/S385) | ABBOTT MEDICAL | 2017-05-05 |
| St Jude Medical Epic HF System (P030054/S328) | ABBOTT MEDICAL | 2017-05-05 |
| Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT_P) (P070008/S081) | Biotronik, Inc. | 2017-05-05 |
| Anthem And Frontier II CRT-P'S (P030035/S156) | ABBOTT MEDICAL | 2017-05-05 |
| Micra Transcatheter Pacing System (P150033/S020) | Medtronic, Inc. | 2017-05-05 |
| Accent, Identity, Verity, Victory And Zephyr Pacemakers (P880086/S282) | ABBOTT MEDICAL | 2017-05-05 |
| Maestro 4000 Cardiac Ablation System (Controller, Remote and Pods) (P020025/S099) | Boston Scientific | 2017-05-04 |
| PACEMAKER ICD CRT NON IMPLANTED COMPONENTS (P050023/S105) | Biotronik, Inc. | 2017-05-04 |
| PACEMAKER ICD CRT NON IMPLANTED COMPONENTS (P000009/S070) | Biotronik, Inc. | 2017-05-04 |
| Rotablator Rotational Atherectomy System (P900056/S159) | Boston Scientific Corp | 2017-05-04 |
| PACEMAKER/ICD/CRT NON IMPLANTED COMPONENTS (P950037/S171) | Biotronik, Inc. | 2017-05-04 |
| PACEMAKER ICD CRT NON IMPLANTED COMPONENTS (P070008/S079) | Biotronik, Inc. | 2017-05-04 |
| Pacemaker/ICD/CRT non implanted components; PSW 1602.U; HMSC 3.34.0 (P000009/S068) | Biotronik, Inc. | 2017-05-03 |
| Various models of dual chamber ICDS in the Ilivia, Intica, Inlexa Families, Various models of CRT-Ds and Non- CRT-Ds in (P050023/S103) | Biotronik, Inc. | 2017-05-03 |
| Wearable Defibrillator Life Vest (P010030/S095) | Zoll Manufacturing Corporation | 2017-05-03 |
| Pacemaker/ICD/CRT non implanted components; PSW 1602.U; HMSC 3.34.0 (P070008/S075) | Biotronik, Inc. | 2017-05-03 |
| TactiCath Quartz Set (P130026/S023) | St Jude Medical | 2017-05-03 |
| Pacemaker/ICD/CRT non implanted components PSW 1602.U, HMSC 3.34.0 (P950037/S166) | Biotronik, Inc. | 2017-05-03 |
| Diamondback 360 Coronary Orbital Atherectomy Device (OAD) (P130005/S016) | Cardiovascular Systems, Inc. | 2017-05-03 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S022) | Cook Ireland, Ltd. | 2017-05-02 |
| NG4 Family of Pulse Generators ICDS. (P960040/S385) | Boston Scientific | 2017-05-02 |
| AFX Endovascular AAA System (P040002/S059) | Endologix, LLC | 2017-05-02 |
| NG4 Family of Pulse Generators CRT-DS (P010012/S436) | Boston Scientific Corp | 2017-05-02 |
| Essentio, Proponent, Accolade MRI. (P150012/S028) | Boston Scientific | 2017-05-01 |
| EDWARDS INTUITY VALVE SYSTEM (P150036/S001) | Edwards Lifesciences, LLC | 2017-05-01 |
| Valitude, Visionist (P030005/S154) | Guidant Corp. | 2017-05-01 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VAlVE (P130009/S066) | Edwards Lifesciences, LLC | 2017-05-01 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S154) | Edwards Lifesciences, LLC | 2017-05-01 |
| Relay Thoracic Stent-Graft with Plus Delivery System (P110038/S015) | Bolton Medical, Inc. | 2017-05-01 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S025) | Edwards Lifesciences, LLC | 2017-05-01 |
| Pacemaker Models Advantio & Ingenio (N970003/S205) | Boston Scientific Corp | 2017-05-01 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S015) | Medtronic, Inc. | 2017-05-01 |
| Essento, Proponent, Accolade, Altrua (N970003/S206) | Boston Scientific Corp | 2017-05-01 |