| REVO MRI IPG (P090013/S181) | Medtronic, Inc. | 2015-04-13 |
| CAPSURE SENSE LEAD, VITATRON CRYSTALLINE LEAD (P830061/S119) | Medtronic Cardiac Rhythm Disease Management | 2015-04-10 |
| LIVEWIRE TC ABLATION CATHETER (P960016/S046) | St Jude Medical | 2015-04-09 |
| THERAPY DUAL 8 CATHETER (P040042/S028) | Irvine Biomedical,Inc.(Ibi) | 2015-04-09 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S013) | Cardiva Medical, Inc. | 2015-04-09 |
| REGENT,STANDARD,MASTERS MECHANICAL HEART VALVES (P810002/S096) | ABBOTT MEDICAL | 2015-04-09 |
| THERAPY CATHETER (P040014/S023) | Irvine Biomedical, Inc. | 2015-04-09 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S052) | Zoll Manufacturing Corporation | 2015-04-09 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S011) | Boston Scientific Corp | 2015-04-09 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S038) | Boston Scientific Corporation | 2015-04-09 |
| IFORIA/ILESTO/INVENTRA/IPERIA/ITREVIA 5/7 DR-T/VR-T/VR-T DX, & VARIOUS LUMAX ICDS; IFORIA/ILESTO/IPERIA/ITREVIA 5/7 HF-T (P050023/S083) | Biotronik, Inc. | 2015-04-09 |
| STATOS LV/LV-T, EVIA/ENTOVIS HF/HF-T (P070008/S060) | Biotronik, Inc. | 2015-04-09 |
| THERAPY COOL PATH CATHETER (P060019/S028) | Irvine Biomedical, Inc. | 2015-04-09 |
| BELOS/LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T (P000009/S061) | Biotronik, Inc. | 2015-04-09 |
| THERAPY COOL PATH DUO CATHETER (P110016/S012) | ABBOTT MEDICAL | 2015-04-09 |
| ACTROS/AXIOS DR/SR/SLR/D/S, BA03 DDDR, CYLOS DR/DR-T/VR, DROMOS DR/SR/SL, KAIROS DR/SR/SL/D/S, PHILOS DR/D (P950037/S148) | Biotronik, Inc. | 2015-04-09 |
| ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-P'S (P030035/S132) | ABBOTT MEDICAL | 2015-04-08 |
| PROMUS ELEMENT PLUS AND PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S104) | Boston Scientific Corp | 2015-04-08 |
| RESOLUTE INTEGRITY ZOTAROLIMUS_ELUTING CORONARY STENT SYSTEM (P110013/S049) | Medtronic Vascular | 2015-04-08 |
| PROMOTE/+/RF/Q, ACCEL/ QUADR;UNIFY ASSURA/ QUADRA, EPIC+/HF/HF+/II HF/II+ HF,ATLAS+HF/II HH/II+ H FAMILY OF CRT-D FAMILY (P030054/S283) | ABBOTT MEDICAL | 2015-04-08 |
| CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICDS (P910023/S354) | ABBOTT MEDICAL | 2015-04-08 |
| ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS (P880086/S254) | ABBOTT MEDICAL | 2015-04-08 |
| CARDIOMEMS HF SYSTEM (P100045/S004) | ABBOTT MEDICAL | 2015-04-08 |
| BLAZER II XP, BLAZER PRIME XP AND INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S067) | Boston Scientific | 2015-04-06 |
| BLAZER II, BLAZER II HTD AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS (P920047/S076) | Boston Scientific Corp | 2015-04-06 |
| IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS ANGIOPLASTY BALLOON CATHETER (P140010/S004) | Medtronic, Inc. | 2015-04-06 |
| CHILLI II COOLED ABLATION CATHETERS (P980003/S056) | Boston Scientific Corp | 2015-04-06 |
| CRYOCONSOLE (P100010/S048) | Medtronic Cryocath, LP | 2015-04-03 |
| CRYOCONSOLE (P020045/S066) | Medtronic Cryocath, LP | 2015-04-03 |
| PEARL 8.0 HANDPIECE (P970029/S027) | Cryolife, Inc. | 2015-04-03 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S075) | W. L. Gore & Associates, Inc. | 2015-04-03 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S041) | W. L. Gore & Associates, Inc. | 2015-04-03 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S055) | Abbott Vascular | 2015-04-02 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S053) | St Jude Medical | 2015-04-02 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S014) | Medtronic Vascular, Inc. | 2015-04-02 |
| INOGEN, ORIGEN AND DYNAGEN CRT-D'S (P010012/S386) | Boston Scientific Corp | 2015-04-02 |
| ADAPTA, VERSIA, SENSIA IPG, ADVISA DR IPG, ADVISA SR MRI IPG, ADVISA DR MRI IPG AND RELIA IPG (P980035/S416) | Medtronic, Inc. | 2015-04-02 |
| VERSATRAX IPG (P820003/S133) | Medtronic Cardiac Rhythm Disease Management | 2015-04-02 |
| INOGEN, ORIGEN AND DYNAGEN ICD'S (P960040/S344) | Boston Scientific | 2015-04-02 |
| SPRINT QUATTRO LEAD (P920015/S150) | Medtronic, Inc. | 2015-04-02 |
| REVO MRI IPG (P090013/S180) | Medtronic, Inc. | 2015-04-02 |
| ATTAIN ABILITY LEAD (P080006/S077) | Medtronic, Inc. | 2015-04-02 |
| ATAKR RADIO FREQUENCY (RF) CATHETER ABLATION SYSTEM (P930029/S050) | Medtronic, Inc. | 2015-04-02 |
| PROTEGE GPS CAROTID STENT SYSTEM, PROTEGE GPS SELF-EXPANDING PERIPHERAL STENT SYSTEM (P060001/S023) | Medtronic Vascular, Inc. | 2015-04-02 |
| THORATEC HEARTMATE II LVAS (P060040/S040) | ABBOTT MEDICAL | 2015-04-01 |
| ARCTIC FRONT/ ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER FAMILIES OF DEVICES (P100010/S047) | Medtronic Cryocath, LP | 2015-04-01 |
| FREEZOR CARDIAC CRYO-ABLATION CATHETER FAMILIES AND THE ARTIC FRONT (P020045/S065) | Medtronic Cryocath, LP | 2015-04-01 |
| ON-X PROSTHETIC HEART VALVE (P000037/S030) | On-X Life Technologies, Inc. | 2015-04-01 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S012) | Cardiva Medical, Inc. | 2015-03-31 |
| MEDTRONIC COREVALVE (TM) SYSTEM (P130021/S011) | Medtronic, Inc. | 2015-03-31 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S072) | W. L. Gore & Associates, Inc. | 2015-03-31 |
| ANGIOJET ULTRA THROMBECTOMY SYSTEM CONSOLE (P980037/S045) | Boston Scientific Corp | 2015-03-31 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S111) | W. L. Gore & Associates, Inc. | 2015-03-31 |
| MEDTRONIC COREVALVE SYSTEM (P130021/S010) | Medtronic, Inc. | 2015-03-30 |
| MAXIMO II, PROTECTA, PROTECTA XT, SECURA, & VIRTUOSO II DR/VR ICD'S (P980016/S521) | Medtronic Cardiac Rhythm Disease Management | 2015-03-30 |
| CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, & PROTECTA XT CRT-D'S (P010031/S485) | Medtronic Cardiac Rhythm Disease Management | 2015-03-30 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S031) | Boston Scientific Corp | 2015-03-27 |
| INVIVE, INTUA CRT PS (P030005/S118) | Guidant Corp. | 2015-03-27 |
| RX HERCULINK ELITE RENAL STENT SYSTEM (P110001/S012) | Abbott Vascular | 2015-03-27 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S060) | Zoll Manufacturing Corporation | 2015-03-27 |
| ADVANTIO, INGENIO, VITALIO, FORMIO PGS (N970003/S172) | Boston Scientific Corp | 2015-03-27 |
| REGENT MECHANICAL HEART VALVE (P810002/S095) | ABBOTT MEDICAL | 2015-03-26 |
| TACTICATH QUARTZ SET (P130026/S002) | St Jude Medical | 2015-03-26 |
| VASCADE CLOSURE SYSTEM (P120016/S011) | Cardiva Medical, Inc. | 2015-03-26 |
| ON-X PROSTHETIC HEART VALVE (P000037/S039) | On-X Life Technologies, Inc. | 2015-03-26 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S075) | Terumo Medical Corporation | 2015-03-26 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S056) | Medtronic | 2015-03-25 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S055) | Medtronic | 2015-03-25 |
| ENDURANT STENT GRAFT SYSTEM, ENDURANT (II/IIS) STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-ILIAC (AUI) STENT GRAFT SYSTEM (P100021/S045) | Medtronic Vascular | 2015-03-25 |
| BLAZER II XP ABLATION CATHETERS, INTELLATIP MIFI XP ABLATION CATHETERS, ELECTROPHYSIOLOGY CABLES ASSOICATED WITH CARDIAC (P020025/S068) | Boston Scientific | 2015-03-24 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S039) | ABBOTT MEDICAL | 2015-03-24 |
| BLAZER II /BLAZER II HTD,BLAZER PRIME (XP/HTD) ABLATION CATHETERS, ELECTROPHYSIOLOGY CABLES (P920047/S077) | Boston Scientific Corp | 2015-03-24 |
| CHILLI II COOLED ABLATION SYSTEM (P980003/S057) | Boston Scientific Corp | 2015-03-24 |
| EZ STEER NAV DS (P010068/S046) | Biosense Webster, Inc. | 2015-03-23 |
| EZ STEER NAV (P990025/S045) | Biosense Webster, Inc. | 2015-03-23 |
| INVIVE AND INTUA CRT-PS (P030005/S117) | Guidant Corp. | 2015-03-23 |
| EZ STEER THERMOCOOL NAV, THERMOCOOL SF NAV (P030031/S067) | Biosense Webster, Inc. | 2015-03-23 |
| EZ STEER THERMOCOOL NAV (P040036/S050) | Biosense Webster, Inc. | 2015-03-23 |
| IMPELLA 2.5 System (P140003) | Abiomed, Inc. | 2015-03-23 |
| ADVANTIO, INGENIO AND VITALIO PACEMAKERS (N970003/S171) | Boston Scientific Corp | 2015-03-23 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S029) | Edwards Lifesciences, LLC | 2015-03-20 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S053) | Edwards Lifesciences, LLC | 2015-03-20 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S066) | Edwards Lifesciences, LLC | 2015-03-20 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S010) | Cardiva Medical, Inc. | 2015-03-20 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S040) | W. L. Gore & Associates, Inc. | 2015-03-20 |
| STRATOS LV/LV-T, EVIA HF/HF-T, ENTOVIS HF/HF-T CRT-P'S (P070008/S057) | Biotronik, Inc. | 2015-03-19 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S104) | MicroPort CRM USA, Inc. | 2015-03-19 |
| ENTOVIS DR-T,DR,SR-T,SR; ELUNA 8 DR-T PROMRI,DR PROMRI,SR-T PRMRI,SR PROMRI;SETROX S53,S60;SAFIO S53,S60 (P950037/S142) | Biotronik, Inc. | 2015-03-19 |
| ACUITY SPIRAL LEADS (P010012/S383) | Boston Scientific Corp | 2015-03-19 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S534) | Medtronic Cardiac Rhythm Disease Management | 2015-03-19 |
| PARADYM (VR/DR) 8750, PARADYM RF (VR/DR) 9750(ZL101),PARADYM RF (VR/DR) 9750 (ZL102),INTENSIA (VR/DR) (P980049/S108) | MicroPort CRM USA, Inc. | 2015-03-19 |
| EZ STEER DS BI-DIRECTIONAL CATHETER, CELSIUS CATHETER (P950005/S056) | Biosense Webster, Inc. | 2015-03-19 |
| BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S (P000009/S060) | Biotronik, Inc. | 2015-03-19 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S046) | W. L. Gore & Associates, Inc. | 2015-03-19 |
| THERMOCOOL SMART TOUCH BI-DIRECTIONAL CATHETERS (P040036/S049) | Biosense Webster, Inc. | 2015-03-19 |
| EZ STEER NAV BI-DIRECTIONAL CATHETER AND NAVISTAR CATHETER (P990025/S044) | Biosense Webster, Inc. | 2015-03-19 |
| PARADYM CRT-D 8750,PARADYM RF CRT-D 9750 (ZL101), PARADYM RF CRT-D 9750 (ZL 102) AND INTENSIA CRT-D (P060027/S075) | MicroPort CRM USA, Inc. | 2015-03-19 |
| IFORIA/ILESTO 5/7 DR-T/VR-T/VR-T DX/HF-T; KRONOS LV-T, VARIOUS LUMAX MODELS CRT-D'S (P050023/S081) | Biotronik, Inc. | 2015-03-19 |
| EZ STEER NAV DS BI-DIRECTIONAL CATHETERS (P010068/S045) | Biosense Webster, Inc. | 2015-03-19 |
| ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (P110028/S015) | Abbott Vascular, Inc. | 2015-03-19 |