| In.Pact Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Chatheter (P140010/S045) | Medtronic, Inc. | 2019-05-23 |
| Open Irigation (OI) Ablation Catheter families: Blazer OI, IntellaTip MiFi OI, IntellaNav OI, and IntellaNav MiFi OI Abl (P150005/S046) | Boston Scientific Corp | 2019-05-23 |
| Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix DCB) (P130024/S027) | Lutonix | 2019-05-23 |
| StarClose SE Vascular Closure System (P050007/S038) | Abbott Vascular Devices | 2019-05-23 |
| ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE (N970003/S234) | Boston Scientific Corp | 2019-05-22 |
| Impella RP (P170011/S011) | Abiomed, Inc. | 2019-05-21 |
| EMBLEM Programmer (P110042/S123) | Boston Scientific Corporation | 2019-05-21 |
| Optimizer Smart System (IPG) (P180036/S001) | Impulse Dynamics (Usa), Inc. | 2019-05-21 |
| Trifecta Valve and Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S040) | ABBOTT MEDICAL | 2019-05-20 |
| Advisa DR IPG, Advisa DR MRI VR ICD, Advisa DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR IPG, Astra X (P980035/S590) | Medtronic, Inc. | 2019-05-20 |
| 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/S666) | Medtronic Cardiac Rhythm Disease Management | 2019-05-20 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Mirro MRI DR ICD, Primo MRI DR ICD, Protecta ICD, Pro (P980016/S706) | Medtronic Cardiac Rhythm Disease Management | 2019-05-20 |
| Life Vest Wearable Defibrillator (P010030/S117) | Zoll Manufacturing Corporation | 2019-05-20 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S404) | Medtronic, Inc. | 2019-05-20 |
| Biocor, Biocor Supra, Epic, and Epic Supra Valves (P040021/S041) | ABBOTT MEDICAL | 2019-05-20 |
| Adapta, Versa, and Sensia IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, (P980035/S591) | Medtronic, Inc. | 2019-05-20 |
| Epicardial Patch Lead (P900061/S153) | Medtronic Cardiac Rhythm Disease Management | 2019-05-20 |
| LIFEPAK Automated External Defibrillators (AED) (P160026/S008) | Physio-Control, Inc. | 2019-05-17 |
| MANTA Vascular Closure Device (P180025/S002) | Teleflex Medical, LLC | 2019-05-15 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S016) | Medinol, Ltd. | 2019-05-14 |
| GORE TAG Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S106) | W. L. Gore & Associates, Inc. | 2019-05-14 |
| Attain Stability Quad MRI SureScan (P080006/S132) | Medtronic, Inc. | 2019-05-14 |
| Gore Excluder AAA Endoprosthesis (P020004/S165) | W. L. Gore & Associates, Inc. | 2019-05-13 |
| Gore Viatorr Tips Endoprosthesis (P040027/S073) | W. L. Gore & Associates, Inc. | 2019-05-13 |
| CareLink Encore Programmer, CareLink Encore Programmer Head, CareLink SmartSync Device Manager Patient Connector, CareLi (P890003/S410) | Medtronic, Inc. | 2019-05-13 |
| Consulta, Syncra, and Viva CRT-P (P010015/S405) | Medtronic, Inc. | 2019-05-13 |
| Acuity X4 Liners (P010012/S503) | Boston Scientific Corp | 2019-05-13 |
| Gore Viabahn Endoprosthesis and Gore Viabahn Endoprosthesis with Heparin Bioactive Surface (P040037/S132) | W. L. Gore & Associates, Inc. | 2019-05-13 |
| Gore Viabahn Endoprosthesis and Gore Viabahn Endoprosthesis with Heparin Bioactive Surface (P130006/S071) | W. L. Gore & Associates, Inc. | 2019-05-13 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S592) | Medtronic, Inc. | 2019-05-13 |
| Gore Tag Thoracic Endoprosthesis (P040043/S111) | W. L. Gore & Associates, Inc. | 2019-05-13 |
| Gore Viabahn VBX Balloon Expandable Endoprosthesis (P160021/S021) | W. L. Gore & Associates, Inc. | 2019-05-13 |
| Avalus Bioprosthesis (P170006/S011) | Medtronic, Inc. | 2019-05-13 |
| Gore Tigris Vascular Stent (P160004/S028) | W. L. Gore & Associates, Inc. | 2019-05-13 |
| In.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S044) | Medtronic, Inc. | 2019-05-10 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S007) | Boston Scientific Corp | 2019-05-09 |
| lnnova Self-Expanding Stent System (P140028/S039) | Boston Scientific Corporation | 2019-05-09 |
| LIFEPAK® 20e defibrillator/monitor (P160026/S006) | Physio-Control, Inc. | 2019-05-09 |
| Epic Vascular Self-Expanding Stent System (P110035/S049) | Boston Scientific Corp | 2019-05-09 |
| Artic Front Advance Cardiac CryoAblation Catheters (P100010/S092) | Medtronic Cryocath, LP | 2019-05-08 |
| CoolFlow Irrigation Tubing Set (P990071/S040) | Biosense Webster, Inc. | 2019-05-08 |
| Pulse Geneerator, Permanent, Implantable (P950037/S201) | Biotronik, Inc. | 2019-05-07 |
| Tupos LV/ATx and Kronos LV-T CRT-D System (P050023/S131) | Biotronik, Inc. | 2019-05-07 |
| Stratos LV/LV-T CRT-P System (P070008/S103) | Biotronik, Inc. | 2019-05-07 |
| FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enable (Flex SE) (P110016/S062) | ABBOTT MEDICAL | 2019-05-07 |
| Livewire TC Ablation Catheter (Livewire TC) (P960016/S078) | St Jude Medical | 2019-05-07 |
| Tacticath Contact Force Ablation Catheter, Sensor Enabled (Tacticath SE) (P130026/S045) | St Jude Medical | 2019-05-07 |
| Adapta, Versa, Sensia IPG, Attesta DR/SR MRI IPG, Relia IPG, and Sphera DR/SR MRI IPG (P980035/S588) | Medtronic, Inc. | 2019-05-06 |
| IMPELLA 5.0 System (P140003/S051) | Abiomed, Inc. | 2019-05-06 |
| Impella 5.0 (P140003/S049) | Abiomed, Inc. | 2019-05-06 |
| Endurant, Endurant II and Endurant IIs Stent Graft System (P100021/S076) | Medtronic Vascular | 2019-05-05 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S038) | Medtronic Vascular | 2019-05-05 |
| Micra TPS (P150033/S054) | Medtronic, Inc. | 2019-05-03 |
| Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, IntellaTip MiFi Open-Irrigated Abl (P150005/S044) | Boston Scientific Corp | 2019-05-03 |
| Adapta, Versa, Sensia IPG, Attesta DR/SR MRI IPG, Relia IPG, Sphera DR/SR MRI IPG, Astra S DDR/SR MRI IPG, Astra XT DR/S (P980035/S589) | Medtronic, Inc. | 2019-05-03 |
| Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav XP, IntellaNav MiFi XP (P020025/S119) | Boston Scientific | 2019-05-03 |
| Chilli II (P980003/S089) | Boston Scientific Corp | 2019-05-03 |
| Amplia/Claria/Compia MRI CRT-D, Ampla/Claria/Compia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Viva Quad S/XT CRT-D, (P010031/S665) | Medtronic Cardiac Rhythm Disease Management | 2019-05-03 |
| Blazer II, Blazer II HTD, Blazer Prime HTD, IntellaNav ST (P920047/S115) | Boston Scientific Corp | 2019-05-03 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S091) | Medtronic Cryocath, LP | 2019-05-03 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Ballon (P160049/S005) | The Spectranetics Corp. | 2019-05-03 |
| Ever MRI DF-1 ICD, Ever MRI ICD, Ever S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Visia A (P980016/S705) | Medtronic Cardiac Rhythm Disease Management | 2019-05-03 |
| Percepta/Serena/Solara Bipolar CRT-P, Percepta/Serena adn Solara Quadripolar CRT-P, Consulta, Syncra and Viva CRT-P (P010015/S403) | Medtronic, Inc. | 2019-05-03 |
| LIFEPAK CR2 Defibrillator (P170018/S003) | Physio-Control, Inc. | 2019-05-02 |
| VICI VENOUS STENT System (P180013) | Boston Scientific Corporation | 2019-05-02 |
| TMR Holmium Laser System (P970029/S039) | Cryolife, Inc. | 2019-05-02 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S004) | Boston Scientific Corp | 2019-05-02 |
| ROTAPRO Rotational Atherectomy System Console (P900056/S176) | Boston Scientific Corp | 2019-05-02 |
| Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, Advisa SR MRI, Astra S DR MRI, Astra S SR MRI, Astra XT DR MRI, Astra X (P980035/S586) | Medtronic, Inc. | 2019-05-01 |
| Arctic Front, Front Advance Cardiac Cryoablation, Freezor MAX & CryoConsoleSystem (P100010/S086) | Medtronic Cryocath, LP | 2019-05-01 |
| Cordis EXOSEAL Vascular Closure Device (P100013/S019) | Cordis US Corporation | 2019-05-01 |
| Consulta, Percepta Bipolar, Percepta Quadripolar, Serena Bipolar, Serena Quadripolar, Solara Bipolar, Solara Quadripolar (P010015/S402) | Medtronic, Inc. | 2019-05-01 |
| HV Splitter/Adaptor kit, Spriint Quattro Lead (P920015/S228) | Medtronic, Inc. | 2019-05-01 |
| Amplia MRI, Amplia MRI Quad, Brava, Brava Quad, Claria MRI, Claria MRI Quad, Consulta, Protecta, Protecta XT, Viva Quad (P010031/S664) | Medtronic Cardiac Rhythm Disease Management | 2019-05-01 |
| HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) (P160054/S018) | ABBOTT MEDICAL | 2019-05-01 |
| Evera MRI DF-1, Evera MRI, Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Mirro MRI DR, Mirro MRI VR, Primo MRI DR, P (P980016/S704) | Medtronic Cardiac Rhythm Disease Management | 2019-05-01 |
| Cordis S.M.A.R.T. CONTROL / S.M.A.R.T. Vascular (P120002/S015) | Cordis US Corporation | 2019-04-30 |
| Cordis S.M.A.R.T. CONTROL Nitinol Stent System (P020036/S040) | Cordis US Corporation | 2019-04-30 |
| ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S012) | Boston Scientific Corporation | 2019-04-30 |
| Cordis PRECISE Nitinol Stent System (P030047/S038) | Cordis US Corporation | 2019-04-30 |
| ThermoCool SmartTouch SF Catheter (P040036/S065) | Biosense Webster, Inc. | 2019-04-29 |
| Corox (ProMRI0 OTW,75,85,S75,L75,LB85 BP; Sentus (ProMRI) OTW,75,85,S75,S85,L75,L85,QP S75S85,S95,l75,l85,L95,S75/49,S75 (P070008/S099) | Biotronik, Inc. | 2019-04-29 |
| Plexa ProMRI DF- S DX 65/15/17; IIivia 7 DR-T; Inrica 5 DTR-T (P980023/S087) | Biotronik, Inc. | 2019-04-29 |
| ThermoCool SmartTouch Catheter (P030031/S095) | Biosense Webster, Inc. | 2019-04-29 |
| SmartAblate Irrigation Pump, nGEN Pump Devices (P990071/S042) | Biosense Webster, Inc. | 2019-04-29 |
| IIivia, 7 HF-T,QP; Intica 7,5 HF-T,QP (P050023/S126) | Biotronik, Inc. | 2019-04-29 |
| Setrox S 53; Safio S 53; Dextrus 4136;TILDA R53;Solia S 45/53/60, JT 45/53; Siello S53/60/45/53/60/,JT 45/53; (P950037/S198) | Biotronik, Inc. | 2019-04-29 |
| Resolute Onyx Over-the-Wire (OTW) Zotarolimus Eluting Coronary Stent System (P160043/S023) | Medtronic Vascular | 2019-04-26 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S006) | Biotronik AG | 2019-04-25 |
| Ovation iX Abdominal Stent Graft System (P120006/S032) | Endologix, LLC | 2019-04-24 |
| FlexAbility Ablation Catheter, FlexAbility Ablation Catheter, Sensor Enabled (P110016/S061) | ABBOTT MEDICAL | 2019-04-23 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S044) | St Jude Medical | 2019-04-23 |
| LOTUS Edge Valve System (P180029) | Boston Scientific Corporation | 2019-04-23 |
| Relay Thoracic Stent-Graft with Plus Delivery System (P110038/S023) | Bolton Medical, Inc. | 2019-04-19 |
| ANGIO-SEAL Vascular Closure Devices (P930038/S094) | Terumo Medical Corporation | 2019-04-19 |
| ThermaCool SmartTouch SF Bi-directional and ThermoCool SmartTouch SF Uni-directional navigation Catheter (P030031/S097) | Biosense Webster, Inc. | 2019-04-19 |
| ThermoCool SmartTouch Uni-directional and ThermoCool SmartTouch Bi-directional navigation Catheter (P040036/S067) | Biosense Webster, Inc. | 2019-04-19 |
| GORE CARDIOFORM Septal Occluder (P050006/S076) | W. L. Gore & Associates, Inc. | 2019-04-18 |
| Melody TPV System (P140017/S014) | Medtronic, Inc. | 2019-04-18 |
| Amplatzer Septal Occluder (P000039/S066) | ABBOTT MEDICAL | 2019-04-18 |