| Promote+ / Unify Quadra /Unity Assura/ Quadra Assura / Quadra Assura MP (P030054/S335) | ABBOTT MEDICAL | 2017-08-23 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S283) | ABBOTT MEDICAL | 2017-08-23 |
| SmartAblate System Foot Pedal. (P990071/S036) | Biosense Webster, Inc. | 2017-08-23 |
| Microny family of Pacemakers (P970013/S071) | ABBOTT MEDICAL | 2017-08-23 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S008) | ABBOTT MEDICAL | 2017-08-23 |
| Current+ / Fortify / Fortify Assura / Ellipse. (P910023/S391) | ABBOTT MEDICAL | 2017-08-23 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S157) | ABBOTT MEDICAL | 2017-08-23 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/ II HF/ II (P030054/S329) | ABBOTT MEDICAL | 2017-08-23 |
| VenaSeal Closure System (P140018/S006) | Medtronic Vascular, Inc. | 2017-08-22 |
| Endurant, Endurant II and Endurant IIs Stent Graft System (P100021/S067) | Medtronic Vascular | 2017-08-22 |
| Impella 2.5, Impella CP Systems (P140003/S017) | Abiomed, Inc. | 2017-08-22 |
| Assurity, Assurity+, Endurity families of ICD Devices (P880086/S284) | ABBOTT MEDICAL | 2017-08-22 |
| ELCA Catheters (P910001/S095) | Spectranetics Corp. | 2017-08-22 |
| Open Pivot Heart Valve, Open Pivot Aortic Valved Graft (P990046/S049) | Medtronic Ats Medical, Inc. | 2017-08-22 |
| Visual Integrity Inspection (P100010/S067) | Medtronic Cryocath, LP | 2017-08-22 |
| IntellaNav MiFi Open-Irrigated Ablation Catheter (P150005/S017) | Boston Scientific Corp | 2017-08-22 |
| BioGlue Surgical Adhesive (P010003/S027) | Cryolife, Inc. | 2017-08-21 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S002) | Edwards Lifesciences, LLC | 2017-08-21 |
| Impella Ventricular Support Systems (P140003/S024) | Abiomed, Inc. | 2017-08-21 |
| PreveLeak Surgical Sealant / PreveLeak Surgical Sealant 10pk applicator tips (P100030/S010) | Baxter Healthcare Corporation | 2017-08-21 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S146) | W. L. Gore & Associates, Inc. | 2017-08-18 |
| Micra Transcatheter Pacing System (P150033/S026) | Medtronic, Inc. | 2017-08-18 |
| GORE TAG Thoracic Endoprosthesis (P040043/S094) | W. L. Gore & Associates, Inc. | 2017-08-18 |
| Voltage Ceramic Capacitors (P110042/S090) | Boston Scientific Corporation | 2017-08-18 |
| Flextome Cutting Balloon Microsurgical Dilatation Device/Wolverine Coronary Cutting Balloon Monorail (MR) / Wolverine Co (P950020/S081) | Boston Scientific Corp | 2017-08-18 |
| Percepta Bipolar CRT-P/ Percepta Quadripolar CRT-P/ Serena Bipolar CRT-P/ Serena Quadripolar CRT-P/ Solar Bipolar CRT-P/ (P010015/S339) | Medtronic, Inc. | 2017-08-17 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S104) | Boston Scientific | 2017-08-17 |
| PROMUS Element Plus Everolimus-Eluting Stent System/ PROMUS PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent (P110010/S143) | Boston Scientific Corp | 2017-08-17 |
| Thoratec, HeartMate II, Ventricular Assist System (P060040/S067) | ABBOTT MEDICAL | 2017-08-17 |
| Rotablator Rotational Atherectomy System (P900056/S163) | Boston Scientific Corp | 2017-08-17 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S023) | Boston Scientific Corp | 2017-08-17 |
| REBEL Platinum CHromum Coronary Stent System (P130030/S042) | Boston Scientific Corp | 2017-08-17 |
| Express SD Monorail Premounted Stent System (P060006/S084) | Boston Scientific Corp | 2017-08-17 |
| IN.PACT Admiral Paclitaxel-Coated Balloon Catheter (P140010/S036) | Medtronic, Inc. | 2017-08-17 |
| HeartWare Left Ventricular Assist Device System (P100047/S103) | Medtronic | 2017-08-17 |
| Chilli II Coole dAblation Catheter and Cable (P980003/S077) | Boston Scientific Corp | 2017-08-17 |
| ASTRA S DR MRI IPG/ ASTRA S SR MRI IPG / ASTRA XT DR MRI IPG / ASTRA XT SR MRI IPG (P980035/S515) | Medtronic, Inc. | 2017-08-17 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S100) | Boston Scientific Corp | 2017-08-17 |
| Endurant Stent Graft System (P100021/S066) | Medtronic Vascular | 2017-08-17 |
| Blind plug BS IS4 (P050023/S111) | Biotronik, Inc. | 2017-08-16 |
| CapSure Sense Lead/CapSure SP Novus Lead/CapSureSense Lead/Vitatron Crystalline Lead (P830061/S149) | Medtronic Cardiac Rhythm Disease Management | 2017-08-16 |
| Setrox S53, S60, Safio S 53, S 60, Solia S 45, S 53, S 60, Siello S 45, S 53, s 60, Blind plug BS IS-1 (P950037/S177) | Biotronik, Inc. | 2017-08-16 |
| Attain StarFix Lead (P060039/S081) | Medtronic, Inc. | 2017-08-16 |
| CapSureFix Novus MRI SureScan Lead (P930039/S170) | Medtronic, Inc. | 2017-08-16 |
| Azure XT SR / DR MRI SureScan, Azure S SR / S DR MRI SureScan , Software Model (P980035/S506) | Medtronic, Inc. | 2017-08-16 |
| CapSureFix MRI Lead (P090013/S262) | Medtronic, Inc. | 2017-08-16 |
| SelectSecure MRI SureScan Lead (P030036/S095) | Medtronic Cardiac Rhythm Disease Management | 2017-08-16 |
| Y Adaptor/Extender Kit/Sprint Quattro Lead/Subcutaneous Lead (P920015/S201) | Medtronic, Inc. | 2017-08-16 |
| Attain OTW LV Lead (P010015/S342) | Medtronic, Inc. | 2017-08-16 |
| CapSureFix Lead/CapSureFix Novus Lead/Vitatron Crystalline Active Fixation Lead (P930039/S175) | Medtronic, Inc. | 2017-08-16 |
| CapSure Sense MRI SureScan Lead (P830061/S145) | Medtronic, Inc. | 2017-08-16 |
| CapSure Epicardial Pacing Lead (P950024/S075) | Medtronic, Inc. | 2017-08-16 |
| CapSure SP Novus Lead/CapSure SP Z Lead/CapSure Z Novus Lead/Vitatron Impulse II Lead (P850089/S127) | Medtronic Cardiac Rhythm Disease Management | 2017-08-16 |
| Attain Ability Lead (P080006/S113) | Medtronic, Inc. | 2017-08-16 |
| SelectSecure Lead (P030036/S096) | Medtronic Cardiac Rhythm Disease Management | 2017-08-16 |
| Edora 8 HF-T QP, Edora 8 HF-T/QP, Evity 8 HF-T/QP,Evity 8 HF-T/QP, Corox (ProMRI) OTW 85 BP, L85 BP, S 85 BP, Sentus (Pr (P070008/S084) | Biotronik, Inc. | 2017-08-16 |
| Myocardial Pacing Lead (P120017/S010) | Medtronic, Inc. | 2017-08-16 |
| Device Command Library (DCL), CareLine Express (P890003/S374) | Medtronic, Inc. | 2017-08-16 |
| CapSure VDD 2 Lead/Vitatron Brilliant S+ VDD Lead (P890003/S379) | Medtronic, Inc. | 2017-08-16 |
| SQ-RX, Emblem, Emblem MRI S-ICD (P110042/S089) | Boston Scientific Corporation | 2017-08-16 |
| CapSureFix MRI SureScan Lead (P090013/S256) | Medtronic, Inc. | 2017-08-16 |
| Edwards Crimper model 9600CR (P140031/S041) | Edwards Lifesciences, LLC | 2017-08-15 |
| Sapien 3 - Transcatheter Heart Valve and Accessories (P140031/S051) | Edwards Lifesciences, LLC | 2017-08-15 |
| Gore Viabahn VBX Balloon Expandable Endoprosthesis (P160021/S004) | W. L. Gore & Associates, Inc. | 2017-08-15 |
| Endurity, Endurity Core, Assurity, Assurity+ (P880086/S285) | ABBOTT MEDICAL | 2017-08-14 |
| Endurity MRI, Assurity MRI (P140033/S011) | ABBOTT MEDICAL | 2017-08-14 |
| Adapta, Versa, Sensia IPGs ADSR01, ADDR01, ADDR06, ADDRL1, ADDRS1, VEDR01, ADD01, SEDRL1, SED01, SES01, ADDR03, SEDR01, (P980035/S516) | Medtronic, Inc. | 2017-08-14 |
| Adapta, Versa, Sensia IPG, Relia IPG (P980035/S514) | Medtronic, Inc. | 2017-08-10 |
| BIOSENSE WEBSTER CABLES (P990071/S034) | Biosense Webster, Inc. | 2017-08-10 |
| Endurant, EndurantII, Endurant lls Stent Graft Systems (P100021/S065) | Medtronic Vascular | 2017-08-10 |
| Tryton Side Branch Stent (P150039/S002) | Poseidon Medical, Inc. | 2017-08-10 |
| NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P990025/S049) | Biosense Webster, Inc. | 2017-08-10 |
| BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS (P030031/S074) | Biosense Webster, Inc. | 2017-08-10 |
| Valiant Thoracic Stent Graft System (P100040/S032) | Medtronic Vascular | 2017-08-10 |
| NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER (P040036/S055) | Biosense Webster, Inc. | 2017-08-10 |
| NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER (P010068/S051) | Biosense Webster, Inc. | 2017-08-10 |
| WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER (P950005/S061) | Biosense Webster, Inc. | 2017-08-10 |
| St. Jude Medical Mechanical heart Valves (P810002/S103) | ABBOTT MEDICAL | 2017-08-10 |
| Gore Tigris Vascular Stent (P160004/S005) | W. L. Gore & Associates, Inc. | 2017-08-09 |
| Hancock Modified Orifice (MO) Valved Conduit, Model 150 (P790007/S051) | Medtronic Heart Valves | 2017-08-09 |
| Gore Viabahn Endoprosthesis (P040037/S100) | W. L. Gore & Associates, Inc. | 2017-08-09 |
| Mosaic Bioprosthesis, Models 305 and 310 (P990064/S069) | Medtronic, Inc. | 2017-08-09 |
| GoreViabahn VBX Balloon Expandable Endoprosthesis (P160021/S003) | W. L. Gore & Associates, Inc. | 2017-08-09 |
| Hancock II Bioprosthesis, Models T505 and T510 (P980043/S061) | Medtronic, Inc. | 2017-08-09 |
| Gore Viabahn Endoprosthesis with Heparin Bioactive Surface (P130006/S039) | W. L. Gore & Associates, Inc. | 2017-08-09 |
| Freestyle Bioprosthesis, Model 995, 995SC and 995MS (P970031/S057) | Medtronic, Inc. | 2017-08-09 |
| Hancock Valved Conduit, Model 105 (P870078/S036) | Medtronic, Inc. | 2017-08-09 |
| Terminal Pin Weld Process Monitoring Plan (P010012/S457) | Boston Scientific Corp | 2017-08-08 |
| Emblem Subcutaneous Implantable Cardioverter Defibrillator Pulse Gerator (P110042/S087) | Boston Scientific Corporation | 2017-08-08 |
| EXOSEAL Vascular Closure Device (P100013/S014) | Cordis US Corporation | 2017-08-07 |
| NG3 Implantable Cardiac Defibrillators, Autogen, Dynagen, Inogen, Origen ICD's; NG4 ICDs- Momentum, Vigilant, Perciva,Re (P960040/S400) | Boston Scientific | 2017-08-07 |
| Resolute Onyx Zotarolimus Eluting Coronary Stent System (P160043/S004) | Medtronic Vascular | 2017-08-07 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S452) | Boston Scientific Corp | 2017-08-07 |
| CRT-D Resynchronization Devices COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, (P010012/S450) | Boston Scientific Corp | 2017-08-07 |
| Astron Pulsar/Pulsar-18 Stent System (P160025/S002) | Biotronik AG | 2017-08-07 |
| HeartWare Ventricular Assist System (P100047/S105) | Medtronic | 2017-08-07 |
| LATITUDE NXT Release Patient Management System (P910077/S160) | Boston Scientific | 2017-08-07 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PERCIVA, RESONATE, MOMENTUM, VIGILANT (P960040/S393) | Boston Scientific | 2017-08-07 |
| HeartWare Ventricular Assist System (P100047/S104) | Medtronic | 2017-08-07 |
| HeartWare Ventricular Assist System (P100047/S106) | Medtronic | 2017-08-07 |