| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S084) | Medtronic Vascular | 2017-11-07 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S010) | Medtronic Vascular | 2017-11-07 |
| Resolute Onyx Coronary Stent System (P160043/S009) | Medtronic Vascular | 2017-11-07 |
| Resolute Integrity Coronary Stent System (P110013/S083) | Medtronic Vascular | 2017-11-07 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S005) | Biotronik AG | 2017-11-06 |
| Astron Pulsar/Pulsar - 18 Stent System (P160025/S003) | Biotronik AG | 2017-11-06 |
| Rotablator Rotational Atherectomy System (P900056/S165) | Boston Scientific Corp | 2017-11-02 |
| Cool Point Tubing Set (P060019/S041) | Irvine Biomedical, Inc. | 2017-11-02 |
| Blazer II XP Cardiac RF Ablation System(also branded as as Blazer (II XP, PRime XP); IntellaTip MiFi XP; IntellaNav XP a (P020025/S108) | Boston Scientific | 2017-11-01 |
| Chilli II Cooled RF Ablation System (P980003/S082) | Boston Scientific Corp | 2017-11-01 |
| REBEL Platinum Chromium Coronary Stent System (Monorail and OVer-The-Wire) (P130030/S045) | Boston Scientific Corp | 2017-11-01 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S167) | Boston Scientific Corp | 2017-11-01 |
| NIRTRAKS Clinical Study (P110004/S023) | Medinol, Ltd. | 2017-11-01 |
| Express SD Monorail Premounted Stent System (P060006/S087) | Boston Scientific Corp | 2017-11-01 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (rebrand of PROMUS Element Plus) (P110010/S147) | Boston Scientific Corp | 2017-11-01 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S098) | Abbott Vascular, Inc. | 2017-11-01 |
| Blazer II Cardiac Ablation System (P920047/S105) | Boston Scientific Corp | 2017-11-01 |
| Impella Ventricular Support System (P140003/S020) | Abiomed, Inc. | 2017-11-01 |
| Blazer Open Irrigated Cardiac Ablation System (P150005/S030) | Boston Scientific Corp | 2017-11-01 |
| Attesta DR MRI SureScan, L DR MRI SureScan, S DR MRI SureScan, SR MRI SureScan, Sphera DR MRI SureScan, L DR MRI SureSca (P980035/S522) | Medtronic, Inc. | 2017-10-31 |
| Gore Tag Thoracic Endoprosthesis (P040043/S096) | W. L. Gore & Associates, Inc. | 2017-10-31 |
| SJM MRI Activator (P140033/S012) | ABBOTT MEDICAL | 2017-10-30 |
| BSC Wolverine Coronary Cutting Balloon (P950020/S084) | Boston Scientific Corp | 2017-10-27 |
| EMBLEM S-ICD (P110042/S094) | Boston Scientific Corporation | 2017-10-27 |
| Valitude, Valitude X4, Visionist, Visionist X4 - Accolade Cardiac Resynchronization Therapy (P030005/S163) | Guidant Corp. | 2017-10-26 |
| Amplia MRI CRT-D/ Quad CRT_D; Brava CRT-D/ Quad CRT-D; Claria MRI CRT-D / Quad CRT-D; Compia MRI Quad CRT-D; Viva Quad X (P010031/S606) | Medtronic Cardiac Rhythm Disease Management | 2017-10-26 |
| Autogen, Dynagen, Inogen, Origen - NG3 Cardiac Resynchronization Therapy / Momentum, Vigilant, Resonate - NG4 CRT-D Devi (P010012/S466) | Boston Scientific Corp | 2017-10-26 |
| Altrua, Essentio, Proponent, Accolade - Accolade Non-MRI Pacemakers (N970003/S215) | Boston Scientific Corp | 2017-10-26 |
| Evera MRI DF ICD /MRI ICD / S DR / S VR / XT DR /XT VR ICD's; Visia AF MRI DFI ICD / AF MRI VR ICD / AF VR ICD. (P980016/S645) | Medtronic Cardiac Rhythm Disease Management | 2017-10-26 |
| PLATINIUM VR 1210, 1240; DR 1510, 1540, CRT-D 1711, 1741 (IS1) and 1744 (IS4) (P060027/S088) | MicroPort CRM USA, Inc. | 2017-10-26 |
| PLATINIUM VR 1210, 1240; DR 1510, 1540, CRT-D 1711, 1741 (P980049/S123) | MicroPort CRM USA, Inc. | 2017-10-26 |
| Autogen, Dynagen, Inogen,Origen / NG3 Implantable Cardiac Defibrillators / Momentur, Vigilant, Perciva, Resonate / NG4 I (P960040/S407) | Boston Scientific | 2017-10-26 |
| Essentio MRI, Proponent MRI, Accolade MRI - Accolade MRI Pacemakers (P150012/S041) | Boston Scientific | 2017-10-26 |
| Angio Seal Vascular Closure Device (P930038/S086) | Terumo Medical Corporation | 2017-10-26 |
| En Trust ICD, Intrinsic ICD, Marquis DR & VR ICD, Maximo II DR ICD, Maximo II ICD, Maximo VR ICD, Protecta ICD /XT ICD, (P980016/S639) | Medtronic Cardiac Rhythm Disease Management | 2017-10-25 |
| Concerto ICD, Concerto II CRT-D, Conslta DR4 ICD, Consulta ICD, InSync Maximo ICD, Maximo II CRT-D, Protecta CRT-D, Prot (P010031/S600) | Medtronic Cardiac Rhythm Disease Management | 2017-10-25 |
| CapSure Fix Novus Lead (4076, 5076) (P930039/S176) | Medtronic, Inc. | 2017-10-24 |
| Navi-Star Diagnostics/ Ablation Deflectable Tip Catheter (P990025/S052) | Biosense Webster, Inc. | 2017-10-24 |
| Safire Bi-Directional Ablation Catheters, Livewire TC Ablation Catheter (P960016/S070) | St Jude Medical | 2017-10-24 |
| CardioMEMS HF System (P100045/S026) | ABBOTT MEDICAL | 2017-10-24 |
| CRTP-Quad: Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bi (P010015/S344) | Medtronic, Inc. | 2017-10-24 |
| Webster Diag/ Ablation Deflectable Tip Catheter (P950005/S064) | Biosense Webster, Inc. | 2017-10-24 |
| Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) (P150028/S001) | NuMED, Inc. | 2017-10-24 |
| Orion: Astra XT DR MIR IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, AZURE S DR MRI IPG, AZURE S SR (P980035/S521) | Medtronic, Inc. | 2017-10-24 |
| Angio Seal Vascular Closure Device (P930038/S085) | Terumo Medical Corporation | 2017-10-24 |
| Biosense Webster Navistar/Celsius Thermo Cool Diagnostic/Ablation Deflectable Tip Catheters (P030031/S080) | Biosense Webster, Inc. | 2017-10-24 |
| Navistar Thermocool Deflectable Diagnostics/Ablation Catheter (P040036/S058) | Biosense Webster, Inc. | 2017-10-24 |
| CapSure Sense Lead (4074, 4574) (P830061/S150) | Medtronic Cardiac Rhythm Disease Management | 2017-10-24 |
| Navistar/Celsius DS Diagnostic/Ablation Deflectable 8MM Tip Catheter (P010068/S053) | Biosense Webster, Inc. | 2017-10-24 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S001) | The Spectranetics Corp. | 2017-10-23 |
| BARD LIFESTENT and LifeStent CLVascular Stent System (P070014/S054) | Bard Peripheral Vascular, Inc. | 2017-10-23 |
| Accolade MRI Pacemakers: ESSENTIO MRI, PROPNENT MRI, ACCOLADE MRI (P150012/S042) | Boston Scientific | 2017-10-20 |
| 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 MRI CR (P010031/S605) | Medtronic Cardiac Rhythm Disease Management | 2017-10-20 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+H (P030054/S320) | ABBOTT MEDICAL | 2017-10-20 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S008) | Medtronic Vascular | 2017-10-20 |
| Accolade Non-MRI Pacemakers: ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE (N970003/S216) | Boston Scientific Corp | 2017-10-20 |
| Accolade Cardiac Resynchronization Therapy-Pacemaker (CRT-P): VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 (P030005/S164) | Guidant Corp. | 2017-10-20 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) Classic Crown (P130005/S018) | Cardiovascular Systems, Inc. | 2017-10-20 |
| Evera MRI ICD/Evera S DR/VR ICD/Evera XT DR/VR ICD/Visia AF MRI VR ICD/Visia AF VR ICD (P980016/S644) | Medtronic Cardiac Rhythm Disease Management | 2017-10-20 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S279) | ABBOTT MEDICAL | 2017-10-20 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic +, Atlas/II/+, Convert/+, Photon (P910023/S382) | ABBOTT MEDICAL | 2017-10-20 |
| Allure Quadra, Quadra Allure MP, Frontier (P030035/S154) | ABBOTT MEDICAL | 2017-10-20 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S381) | ABBOTT MEDICAL | 2017-10-20 |
| Evera MRI ICD/Evera S DR/VR ICD/Evera XT DR/VR ICD/Visia AF MRI VR ICD/Visia AF VR ICD (P980016/S643) | Medtronic Cardiac Rhythm Disease Management | 2017-10-20 |
| Anthem, Allure/RF, Quadra Allure /RF family ofCRT-Ps (P030035/S153) | ABBOTT MEDICAL | 2017-10-20 |
| Assurity, Endurity, Accent, AddVent, Identity, Entity, Paragon III Sustain (P880086/S280) | ABBOTT MEDICAL | 2017-10-20 |
| 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 MRI CR (P010031/S604) | Medtronic Cardiac Rhythm Disease Management | 2017-10-20 |
| Merlin Patient Care System Programmer (P030054/S327) | ABBOTT MEDICAL | 2017-10-20 |
| Promote Accel, Promote Quadra, Unify Assura, Quadra Assura, Epic+/HF/HF+/IIHF/II+HF, Atlas +HF/IIHF/II+HF/III+HF (P030054/S321) | ABBOTT MEDICAL | 2017-10-20 |
| Microny SR+ Regency SC+ (P970013/S070) | ABBOTT MEDICAL | 2017-10-20 |
| Percepta Quad CRT-P MRI SureScan / Percepta CRT-P MRI SureScan / Serena Quad CRT-P MRI SureScan / Splar Quad CRT-P MRI S (P010015/S340) | Medtronic, Inc. | 2017-10-19 |
| Evera MRI ICD/Evera S DR/VR ICD/Evera XT DR/VR ICD/Visia AF MRI VR ICD/Visia AF VR ICD (P980016/S642) | Medtronic Cardiac Rhythm Disease Management | 2017-10-19 |
| MyCareLink Patient Monitor, Device Command Library (DCL) , Device Data Management Application (DDMA) CareLink Express, C (P890003/S378) | Medtronic, Inc. | 2017-10-19 |
| 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 MRI CR (P010031/S603) | Medtronic Cardiac Rhythm Disease Management | 2017-10-19 |
| Fortify / Fortify Assura / Ellipse (P910023/S394) | ABBOTT MEDICAL | 2017-10-18 |
| Unify / Unify Quadra / Unify Assura / Quadra Assura / Quadra Assura MP (P030054/S338) | ABBOTT MEDICAL | 2017-10-18 |
| Durata and Optisure High Voltage Lead (P950022/S110) | ABBOTT MEDICAL | 2017-10-18 |
| Valitude / Valitude X4 / Visionist / Visionist X4 / Accolade Cardiac Resynchronization Therapy Pacemaker (CRT-P) Devices (P030005/S162) | Guidant Corp. | 2017-10-18 |
| Altrua / Essentio / Proponent / Accolade / Accolade Non-MRI Pacemakers (N970003/S214) | Boston Scientific Corp | 2017-10-18 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S148) | W. L. Gore & Associates, Inc. | 2017-10-18 |
| Essentio MRI / Proponent MRI / Accolade MRI / Accp;ade MRI Pacemakers (P150012/S040) | Boston Scientific | 2017-10-18 |
| Stockert 70 Radio Frequency Ablation Generator (P990071/S038) | Biosense Webster, Inc. | 2017-10-17 |
| Navistar Thermo Cool Deflectable Diagnostic/Ablation Catheter (P040036/S061) | Biosense Webster, Inc. | 2017-10-17 |
| Navistar/Celsius Thermo Cool Diagnostic/Ablation Deflectable Tip Catheters (P030031/S084) | Biosense Webster, Inc. | 2017-10-17 |
| Webster Diag./Ablation Deflectable Tip Catheter (P950005/S068) | Biosense Webster, Inc. | 2017-10-17 |
| Navi-Star Diagnostic/Ablation Deflectable Tip Catheter (P990025/S055) | Biosense Webster, Inc. | 2017-10-17 |
| Navistar/Celsius DS Diagnostic/Ablation Deflectable 8MM Tip Catheter (P010068/S056) | Biosense Webster, Inc. | 2017-10-17 |
| AngioJet Ultra XMI / Spiroflex / Spiroflex VG / Distaflex Thrombectomy Set (P980037/S066) | Boston Scientific Corp | 2017-10-16 |
| Current+ CD1211-36, CD2211-36, CD1211-36Q, CD2211-36Q; Fortify CD1231-40, CD1231-40Q, CD2231-40, CD2231-40Q; Fortify Ass (P910023/S393) | ABBOTT MEDICAL | 2017-10-16 |
| Anthem PM3210 NKE; Allure, Allure Quadra PM3120, PM3222, PM3140, PM3242; Quadra Allure MP PM3160, PM3262; (P030035/S160) | ABBOTT MEDICAL | 2017-10-16 |
| Microny 2525T (P970013/S073) | ABBOTT MEDICAL | 2017-10-16 |
| Assurity MRI PM1272, PM2272; Endurity MRI PM1172, PM2172 (P140033/S015) | ABBOTT MEDICAL | 2017-10-16 |
| EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) (P110042/S093) | Boston Scientific Corporation | 2017-10-16 |
| Victory 5816, 5810, 5610; Zephyr 5820, 5826, 5620, 5626; Accent PM1110, PM1210, PM2110, PM2210; Assurity PM1240, PM2240; (P880086/S288) | ABBOTT MEDICAL | 2017-10-16 |
| Durata and Optisure Family of High Voltage Leads (P950022/S111) | ABBOTT MEDICAL | 2017-10-16 |
| Promote+ CD3211-36, CD3211-36Q; Unify CD3231-40, CD3231-40Q; Unify Quadra CD3249-40, CD3249-40Q; Unify Assura CD3257-40, (P030054/S337) | ABBOTT MEDICAL | 2017-10-16 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S002) | Bard Peripheral Vascular, Inc. | 2017-10-13 |
| Resolute Integrity RX Coronary Stent System & Resolute Integrity OTW Cornary Stent System (P110013/S082) | Medtronic Vascular | 2017-10-13 |
| Ovation iX Abdominal Stent Graft System (P120006/S028) | Endologix, LLC | 2017-10-13 |
| Thoratec HeartMate II and HeartMate 3 Ventricular Assist System (LVAS) (P160054/S001) | ABBOTT MEDICAL | 2017-10-12 |