| Micra TPS (P150033/S056) | Medtronic, Inc. | 2019-09-27 |
| ETI-EBK PLUS Aassay (P990043/S030) | DiaSorin, Inc. | 2019-09-27 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead (P850089/S144) | Medtronic Cardiac Rhythm Disease Management | 2019-09-27 |
| Oxford Partial Knee System (P010014/S093) | Biomet Manufacturing Corp | 2019-09-27 |
| Ace Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve (P900061/S155) | Medtronic Cardiac Rhythm Disease Management | 2019-09-27 |
| Attain Ability Lead, Attain Performa Lead and Attain Stability Quad MRI Lead (P080006/S140) | Medtronic, Inc. | 2019-09-27 |
| MAESTRO System Software 8.0 (P000025/S111) | Med-El Corp. | 2019-09-27 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Attesta D (P980035/S605) | Medtronic, Inc. | 2019-09-27 |
| Attain OTW LV Lead, Consulta CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara B (P010015/S419) | Medtronic, Inc. | 2019-09-27 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S341) | Medtronic, Inc. | 2019-09-27 |
| ETI-AB-AUK PLUS assay (P990042/S026) | DiaSorin, Inc. | 2019-09-27 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S193) | Medtronic Neuromodulation | 2019-09-27 |
| ETI MAK-2 PLUS Assay and HBsAg Confirmatory Test (P990038/S030) | DiaSorin, Inc. | 2019-09-27 |
| Myocardial Pacing Lead (P120017/S019) | Medtronic, Inc. | 2019-09-27 |
| ETI-CORE-IGMK PLUS assay (P990044/S027) | DiaSorin, Inc. | 2019-09-27 |
| Attain StarFix Lead (P060039/S096) | Medtronic, Inc. | 2019-09-27 |
| NovaSure Impedance Controlled Endometrial Ablation Device (P010013/S077) | Hologic, Inc. | 2019-09-26 |
| cobas HBV (P150014/S032) | Roche Molecular Systems, Inc. | 2019-09-26 |
| cobas CMV (P160041/S025) | Roche Molecular Systems, Inc. | 2019-09-26 |
| cobas HCV (P150015/S034) | Roche Molecular Systems, Inc. | 2019-09-26 |
| VISTAKON (senofilcon A) - ACUVUE OASYS for Astigmatism Brand Contact Lenses (P040045/S110) | Vistakon, Division of Johnson & Johnson Vision Car | 2019-09-26 |
| LOTUS Edge Valve System (P180029/S012) | Boston Scientific Corporation | 2019-09-26 |
| 8-Channel Adapters (P140009/S049) | ABBOTT MEDICAL | 2019-09-26 |
| Torque Wrench (P010032/S154) | ABBOTT MEDICAL | 2019-09-26 |
| Esteem System (P090018/S038) | Envoy Medical Corporation | 2019-09-26 |
| therascreen EGFR RGQ PCR Kit (P120022/S020) | QIAGEN GmbH | 2019-09-26 |
| EXCLUDER AAA Endoprosthesis (P020004/S168) | W. L. Gore & Associates, Inc. | 2019-09-26 |
| cobas EGFR Mutation Test v2 (P120019/S029) | Roche | 2019-09-25 |
| cobas 4800 BRAF V600 Mutation Test (P110020/S033) | Roche Molecular Systems, Inc. | 2019-09-25 |
| Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, and Resonate Cardiac Resynchronization Therapy Defibrillator (CRT- (P010012/S509) | Boston Scientific Corp | 2019-09-24 |
| Valitude, Valitude X4, Visionist, and Visionist X4 Cardiac Resynchronization Therapy - Pacemaker (CRT-P) (P030005/S189) | Guidant Corp. | 2019-09-24 |
| Precision Spinal Cord Stimulator (SCS) System- (Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage (P030017/S330) | Boston Scientific Corp | 2019-09-24 |
| Essentio, Proponent, and Accolade MRI Pacemakers (P150012/S082) | Boston Scientific | 2019-09-24 |
| RealTime IDH1 (P170041/S001) | Abbott Molecular, Inc. | 2019-09-24 |
| Carpentier-Edwards PERIMOUNT/PERIMOUNT RSR/Magna Pericardial Aortic Bioprosthesis; Carpentir-Edwards PERIMOUNT Theon/PER (P860057/S191) | Edwards Lifesciences, LLC | 2019-09-24 |
| Edwards Intuity Elite Valve System (P150036/S041) | Edwards Lifesciences, LLC | 2019-09-24 |
| Impella 5.5 with SmartAssist (P140003/S050) | Abiomed, Inc. | 2019-09-24 |
| sentus QP LV Lead (P070008/S104) | Biotronik, Inc. | 2019-09-24 |
| Origen, Inogen, Dynagen, Autogen, Vigilant, Resonate, Perciva, and Momentum Implantable Cardioverter Defibrillator (ICD) (P960040/S442) | Boston Scientific | 2019-09-24 |
| Edwards Sapien XT Transcatheter Heart Valve (P130009/S099) | Edwards Lifesciences, LLC | 2019-09-24 |
| EP Passion Initiative (P050023/S132) | Biotronik, Inc. | 2019-09-24 |
| RealTime IDH2 (P170005/S001) | Abbott Molecular, Inc. | 2019-09-24 |
| Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S024) | Boston Scientific Corp | 2019-09-24 |
| Impella 2.5, Impella CP, Impella CP with SmatAssist, Impella 5.0/LD Systems (P140003/S056) | Abiomed, Inc. | 2019-09-24 |
| Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S092) | Edwards Lifesciences, LLC | 2019-09-24 |
| Impella RP System (P170011/S014) | Abiomed, Inc. | 2019-09-24 |
| Essentio, Proponent, Accolade, and Altrua 2 Non-MRI Pacemakers (N970003/S243) | Boston Scientific Corp | 2019-09-24 |
| Edwards Pericardial Aortic/Mitral Bioprosthesis and Edwards Inspiris Resilia Aortic Valve (P150048/S037) | Edwards Lifesciences, LLC | 2019-09-24 |
| AcrySof Intraocular Lenses (P930014/S127) | Alcon Laboratories, Inc. | 2019-09-24 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S015) | Boston Scientific Corp | 2019-09-23 |
| Prometra Programmable Infusion Pump System (P080012/S060) | Infusyn Therapeutics, LLC | 2019-09-23 |
| Innova Vascular Self-Expanding Stent System (P140028/S045) | Boston Scientific Corporation | 2019-09-23 |
| CustomFlex Artificial Iris (P170039/S001) | Humanoptics AG | 2019-09-23 |
| Versant HCV Genotype 2.0 Assay (LiPA) (P160016/S004) | Fujirebio Europe N.V. | 2019-09-20 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone, and the AMS Ambicor Inflatable Penile Prosthesis (P000053/S107) | Boston Scientific Corp | 2019-09-20 |
| SelectSecure MRI SureScan Lead (P030036/S113) | Medtronic Cardiac Rhythm Disease Management | 2019-09-20 |
| Pipeline Flex Embolization Device (P100018/S023) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019-09-20 |
| Cologuard Stool DNA-Based Colorectal Cancer Screening Test (P130017/S029) | Exact Sciences Corporation | 2019-09-20 |
| EluNIR™ Ridaforolimus Eluting Coronary Stent System (P170008/S021) | Medinol, Ltd. | 2019-09-20 |
| MarginProbe System (P110014/S009) | Dilon Medical Technologies, Ltd. | 2019-09-20 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S014) | Celonova Biosciences, Inc. | 2019-09-20 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone (N970012/S167) | Boston Scientific Corp | 2019-09-20 |
| Evolut PRO+ Sysstem (P130021/S059) | Medtronic, Inc. | 2019-09-19 |
| Beta-Cath System (P000018/S050) | Best Vascular, Inc. | 2019-09-19 |
| NeuroPace RNS System (P100026/S063) | NeuroPace, Inc. | 2019-09-19 |
| SynCardia temporary Total Artificial Heart (Tah-t) System (P030011/S072) | Syncardia Systems, LLC | 2019-09-19 |
| LifeVest Wearable Defibrillator (P010030/S121) | Zoll Manufacturing Corporation | 2019-09-19 |
| IDEAL IMPLANT Structured Breast Implant (P120011/S015) | Bimini Health Tech | 2019-09-19 |
| LifeVest Wearable Defibrillator (P010030/S122) | Zoll Manufacturing Corporation | 2019-09-19 |
| Algovita Spinal Cord Stimulation System (P130028/S029) | Nuvectra Corporation | 2019-09-19 |
| Diamondback 360 Coronary Orbital Atherectomy System (P130005/S021) | Cardiovascular Systems, Inc. | 2019-09-19 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S096) | Medtronic Cryocath, LP | 2019-09-19 |
| Durolane (P170007/S004) | Bioventus, LLC | 2019-09-19 |
| Micra Transcatheter Pacemaker System (P150033/S058) | Medtronic, Inc. | 2019-09-19 |
| Autogen, Dynagen, Inogen, and Origen NG3 CRT-Ds and Resonate, Momentum, and Vigilant NG4 CRT-Ds (P010012/S506) | Boston Scientific Corp | 2019-09-18 |
| Autogen, Dynagen, Inogen, and Origen NG3 ICDs and Resonate, Momentum, Vigilant, and Perciva NG4 ICDs (P960040/S440) | Boston Scientific | 2019-09-18 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S007) | Berlin Heart, Inc. | 2019-09-18 |
| Valitude and Visionist Non-MRI CRT-Ps and Valitude X4 and Visionist X4 MRI CRT-Ps (P030005/S186) | Guidant Corp. | 2019-09-18 |
| Micra Transcatheter Pacing System (P150033/S057) | Medtronic, Inc. | 2019-09-18 |
| Essentio, Proponent, and Accolade MRI Pacemakers (P150012/S080) | Boston Scientific | 2019-09-18 |
| Prismaflex TPE2000 Set (P830063/S012) | Vantive US Healthcare, LLC | 2019-09-18 |
| TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (P990040/S029) | Cerenovus, Inc. | 2019-09-18 |
| comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S085) | CooperVision, Inc. | 2019-09-18 |
| Vascade MVP VVCS (P120016/S027) | Cardiva Medical, Inc. | 2019-09-18 |
| TactiCath Quartz Contact Force Ablation Catheter (P130026/S050) | St Jude Medical | 2019-09-18 |
| Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S006) | Stryker Leibinger GmbH & Co KG | 2019-09-18 |
| RxSight Light Adjustable Lens and Light Delivery Device (P160055/S007) | Rxsight, Inc. | 2019-09-18 |
| Altrua 2, Essentio, Proponent, and Accolade Non-MRI Pacemakers (N970003/S241) | Boston Scientific Corp | 2019-09-18 |
| Activa Deep Brain Stimulation Therapy System (P960009/S358) | Medtronic, Inc. | 2019-09-17 |
| Infinity family of DBS IPGs (P140009/S046) | ABBOTT MEDICAL | 2019-09-17 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S442) | Medtronic Neuromodulation | 2019-09-17 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S297) | Medtronic Neuromodulation | 2019-09-17 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S192) | Medtronic Neuromodulation | 2019-09-17 |
| Proclaim family of SCS IPGs (P010032/S149) | ABBOTT MEDICAL | 2019-09-17 |
| Sapien XT Transcatheter Heart Valve and Accessories (P130009/S100) | Edwards Lifesciences, LLC | 2019-09-17 |
| GORE CARDIOFORM Septal Occluder (GSO) (P050006/S077) | W. L. Gore & Associates, Inc. | 2019-09-17 |
| Sapien 3 Transcatheter Heart Valve and Accessories (P140031/S094) | Edwards Lifesciences, LLC | 2019-09-17 |
| Proclaim DRG IPG Clinical Programmer App (P150004/S029) | ABBOTT MEDICAL | 2019-09-17 |
| CardioMessenger Smart 3G (P050023/S135) | Biotronik, Inc. | 2019-09-16 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S028) | Medtronic Vascular | 2019-09-16 |