| BIOGLUE SURGICAL ADHESIVE (P010003/S023) | Cryolife, Inc. | 2017-02-10 |
| PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) (P070008/S077) | Biotronik, Inc. | 2017-02-10 |
| NIRXCELL PMS US STUDY NIRTRAKS (P110004/S021) | Medinol, Ltd. | 2017-02-10 |
| PULSE GENERATOR, PERMANENT, IMPLANTABLE (P950037/S169) | Biotronik, Inc. | 2017-02-10 |
| VALIANT THORACIC STENT GRAFT SYSTEM (P100040/S029) | Medtronic Vascular | 2017-02-09 |
| WOLVERINE CORONARY CUTTING BALLOON (MONORAIL AND OVER-THE-WIRE) (P950020/S079) | Boston Scientific Corp | 2017-02-09 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER THE WIRE) (P130030/S035) | Boston Scientific Corp | 2017-02-09 |
| INTELLANAV XP TEMPERATURE ABLATION CATHETERS (P020025/S094) | Boston Scientific | 2017-02-09 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S063) | Boston Scientific Corp | 2017-02-08 |
| IPERIA 7 VR-T/INVENTRA 7 VR-T (DF-1); IPERIA 7 VR-T/INVENTRA 7 VR-T (DF4) (P050023/S101) | Biotronik, Inc. | 2017-02-08 |
| PHYLAX AV ICD SYSTEM (P000009/S067) | Biotronik, Inc. | 2017-02-08 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S164) | Biotronik, Inc. | 2017-02-08 |
| STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD (P070008/S074) | Biotronik, Inc. | 2017-02-08 |
| LINOX SMART/PROTEGO (ProMRI) S 65;LINOX SMART/PROTEGO (ProMRI) S 75;LINOX SMART/PROTEGO (ProMRI) SD 65/16;LINOX SMART/PR (P980023/S076) | Biotronik, Inc. | 2017-02-08 |
| ON-X (R) PROSTHETIC HEART VALVE, ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, ON-X AORTIC PROSTHETIC HEART VALVE WITH A (P000037/S048) | On-X Life Technologies, Inc. | 2017-02-07 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S487) | Medtronic, Inc. | 2017-02-07 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S056) | Medtronic, Inc. | 2017-02-07 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S319) | Medtronic, Inc. | 2017-02-07 |
| MEDTRONIC FREESTYLE BIOPROSTHESIS (P970031/S054) | Medtronic, Inc. | 2017-02-07 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S014) | Medtronic, Inc. | 2017-02-07 |
| LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S009) | Lutonix | 2017-02-07 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S617) | Medtronic Cardiac Rhythm Disease Management | 2017-02-07 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013/S246) | Medtronic, Inc. | 2017-02-07 |
| MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE (P990064/S065) | Medtronic, Inc. | 2017-02-07 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S576) | Medtronic Cardiac Rhythm Disease Management | 2017-02-07 |
| AMPLATZER PFO OCCLUDER (P120021/S001) | ABBOTT MEDICAL | 2017-02-06 |
| TRIFECTA VALVE, VALVE WITH GLIDE (P100029/S024) | ABBOTT MEDICAL | 2017-02-03 |
| SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE (P040021/S030) | ABBOTT MEDICAL | 2017-02-03 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S035) | Boston Scientific Corp | 2017-02-03 |
| ENDURANT & ENDURANT II STENT GRAFT SYSTEM; ENDURANT II AORTO-UNI-LIAC (AUI) STENT GRAFT SYSTEM; ENDURANT IIs STENT GRAFT (P100021/S060) | Medtronic Vascular | 2017-02-03 |
| MASTERS VALVED GRAFT WITH HEMASHIELD GRAFT TECHNOLOGY (P810002/S100) | ABBOTT MEDICAL | 2017-02-02 |
| 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/S570) | Medtronic Cardiac Rhythm Disease Management | 2017-02-02 |
| EVERA MRI DF-1 ICD, EVERA MRI IDC, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, VISIA AF MRI DF1 IC (P980016/S610) | Medtronic Cardiac Rhythm Disease Management | 2017-02-02 |
| ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011/S013) | Medtronic, Ireland | 2017-02-01 |
| IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S024) | Medtronic, Inc. | 2017-02-01 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S075) | Medtronic Vascular | 2017-02-01 |
| INTEGRITY CORONARY STENT SYSTEM (P030009/S089) | Medtronic, Ireland | 2017-02-01 |
| MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015/S194) | Medtronic, Inc. | 2017-02-01 |
| TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM (P070027/S048) | Medtronic Vascular | 2017-02-01 |
| ENDURANT/ENDURANT II/ ENDURANT IIS STENT GRAFT (P100021/S057) | Medtronic Vascular | 2017-02-01 |
| VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM (P100040/S028) | Medtronic Vascular | 2017-02-01 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S014) | Abbott Vascular (Idef Technologies Inc) | 2017-02-01 |
| COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA (P110040/S011) | Medtronic Vascular | 2017-02-01 |
| COMPLETE SE VASCULAR STENT SYSTEM ILIAC (P090006/S019) | Medtronic Vascular | 2017-02-01 |
| Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software (P140033) | ABBOTT MEDICAL | 2017-01-31 |
| LWS, OSR (P910023/S378) | ABBOTT MEDICAL | 2017-01-31 |
| NIRXCELL COCR CORONARY STENT ON RX SYSTEM (P110004/S016) | Medinol, Ltd. | 2017-01-31 |
| PULSE GENERATOR, PACEMAKER, IMPLANTABLE WITH CARDIAC RESYNCHRONIZATION (CRT-P) (P070008/S080) | Biotronik, Inc. | 2017-01-31 |
| ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-PS (P030035/S151) | ABBOTT MEDICAL | 2017-01-31 |
| Promote/+/RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY,UNIFY ASSURA, UNIFY QUADRA (P030054/S316) | ABBOTT MEDICAL | 2017-01-31 |
| ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS (P880086/S276) | ABBOTT MEDICAL | 2017-01-31 |
| DEFIBRILLATOR, IMPLANTABLE, DUAL CHAMBER, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATION (P050023/S106) | Biotronik, Inc. | 2017-01-31 |
| IMPELLA 2.5 SYSTEM (P140003/S013) | Abiomed, Inc. | 2017-01-31 |
| PULSE GENERATOR, PERMANENT, IMPLANTABLE (P950037/S172) | Biotronik, Inc. | 2017-01-31 |
| GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS (P160021) | W. L. Gore & Associates, Inc. | 2017-01-27 |
| IN PACT ADMIRAL PACLITAXEL BALLOON CATHETER (P140010/S028) | Medtronic, Inc. | 2017-01-26 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S089) | Zoll Manufacturing Corporation | 2017-01-26 |
| ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S004) | Boston Scientific Corporation | 2017-01-26 |
| IMPELLA (P140003/S015) | Abiomed, Inc. | 2017-01-25 |
| ACUITY Spiral Heart Failure Leads (P010012/S438) | Boston Scientific Corp | 2017-01-20 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S157) | Edwards Lifesciences, LLC | 2017-01-19 |
| Tunneling Tool 6996T (P920015/S193) | Medtronic, Inc. | 2017-01-19 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S088) | Zoll Manufacturing Corporation | 2017-01-19 |
| EDWARDS INTUITY ELITE VALVE SYSTEM (P150036/S003) | Edwards Lifesciences, LLC | 2017-01-19 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S074) | Boston Scientific Corporation | 2017-01-19 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S029) | Edwards Lifesciences, LLC | 2017-01-19 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S069) | Edwards Lifesciences, LLC | 2017-01-19 |
| INGEVITY LEADS (P150012/S025) | Boston Scientific | 2017-01-18 |
| Sprint Quattro Lead Models 6935, 6944, 6947 (P920015/S192) | Medtronic, Inc. | 2017-01-18 |
| ARCTIC FRONT CRYOCATHETER SYSTEM (P100010/S060) | Medtronic Cryocath, LP | 2017-01-17 |
| MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM (P100021/S059) | Medtronic Vascular | 2017-01-17 |
| Freezor CryoAblation System (P020045/S078) | Medtronic Cryocath, LP | 2017-01-17 |
| QuickFlex u and Quartet leads (P030054/S311) | ABBOTT MEDICAL | 2017-01-13 |
| IsoFlex Optim leads (P960030/S047) | ABBOTT MEDICAL | 2017-01-13 |
| Durata and Optisure leads (P950022/S095) | ABBOTT MEDICAL | 2017-01-13 |
| ENDURANT,ENDURANT II AND ENDURANT II AOTYO-UNI-LIAC (AUI) STENT GRAFT SYSTEM (P100021/S054) | Medtronic Vascular | 2017-01-13 |
| Tendril SDX, Tendril ST, Tendril STS and Optisense leads (P960013/S085) | ABBOTT MEDICAL | 2017-01-13 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S077) | Medtronic Vascular | 2017-01-13 |
| HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (P160008) | Heartsine Technologies, Ltd. | 2017-01-12 |
| Incepta, Energen, Punctua, Autogen, Dynagen, Inogen, Origen, Resonate, Vigilant, Momentum, and Perciva ICDs (P960040/S387) | Boston Scientific | 2017-01-11 |
| Incepta, Energen, Punctua, Autogen, Dynagen, Inogen, Origen, Resonate, Vigilant, and Momentum CRT-Ds (P010012/S442) | Boston Scientific Corp | 2017-01-11 |
| Fromio, Vitalio, Ingenio, Advantio, Altrua, Altrua 2, Accolade, Proponent and Essentio (N970003/S201) | Boston Scientific Corp | 2017-01-11 |
| Intua, Invive, Valitude, and Visionist CRT-Ps (P030005/S149) | Guidant Corp. | 2017-01-11 |
| Accolade MRI, Proponent MRI, and Essentio MRI (P150012/S024) | Boston Scientific | 2017-01-11 |
| Emblem and Emblem MRI S-ICDs (P110042/S073) | Boston Scientific Corporation | 2017-01-11 |
| GORE CARDIOFORM SEPTAL OCCLUDER (P050006/S056) | W. L. Gore & Associates, Inc. | 2017-01-11 |
| INGEVITY NON-MRI LEAD & INGEVITY MRI LEAD (P150012/S023) | Boston Scientific | 2017-01-10 |
| ACUITY X4 STRAIGHT/SPIRAL S/SPIRAL L MODELS (P010012/S441) | Boston Scientific Corp | 2017-01-10 |
| ENDOTAK RELIANCE SYSTEM (P910073/S140) | Boston Scientific | 2017-01-10 |
| PERCEVAL HEART VALVE (P150011/S006) | Corcym S.r.l. | 2017-01-10 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S053) | W. L. Gore & Associates, Inc. | 2017-01-09 |
| DURATA AND OPTISURE LEADS (HV ACTIVE AND PASSIVE) (P950022/S098) | ABBOTT MEDICAL | 2017-01-08 |
| IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S022) | Boston Scientific | 2017-01-08 |
| QUICKFLEX U AND QUARTET LEADS (CRT) (P030054/S315) | ABBOTT MEDICAL | 2017-01-08 |
| ISOFLEX OPTIM LEADS (LV PASSIVE) (P960030/S049) | ABBOTT MEDICAL | 2017-01-08 |
| TENDRIL SDX, TENDRIL ST, TENDRIL STS AND OPTISENSE LEADS (LV ACTIVE) (P960013/S087) | ABBOTT MEDICAL | 2017-01-08 |
| ARCTIC FRONT & ARCTIC ADVANCED CARDIAC CRYOABLATIN CATHETER SYSTEM (P100010/S061) | Medtronic Cryocath, LP | 2017-01-06 |
| Evera MRI, S DR, S VR, XT DR, XTVR ICD's; Maximo II ICD; Protecta VR, XT ICDs; Secura DR ICD's; Virtuose II DR/VR ICD; V (P980016/S606) | Medtronic Cardiac Rhythm Disease Management | 2017-01-06 |
| BUZZER COMPONENT (P110042/S072) | Boston Scientific Corporation | 2017-01-06 |
| Amplia MRI/MRI Quad CRT-D's; Brava CRT-D; Compia MRI/MRI Quad CRT-Ds; Concerto II CRT-D; Consulta CRT-D; Maximo II CRT-D (P010031/S567) | Medtronic Cardiac Rhythm Disease Management | 2017-01-06 |