| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S504) | Medtronic Cardiac Rhythm Disease Management | 2015-07-20 |
| VALITUDE AND VALITUDE X4 CRT-P (P030005/S125) | Guidant Corp. | 2015-07-20 |
| ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 PACEMAKERS (N970003/S179) | Boston Scientific Corp | 2015-07-20 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S540) | Medtronic Cardiac Rhythm Disease Management | 2015-07-20 |
| REVO MRI SURESCAN IPG (P090013/S192) | Medtronic, Inc. | 2015-07-20 |
| LATITUDE INDUCTIVE COMMUNICATOR ; LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM) (P910077/S150) | Boston Scientific | 2015-07-20 |
| REVO MRI SURESCAN IPG (P090013/S190) | Medtronic, Inc. | 2015-07-20 |
| OVATION IX ABDOMINAL STENT GRAFT SYSTEM (P120006/S020) | Endologix, LLC | 2015-07-17 |
| COROX OTW 75-UP STEROID,COROX OTW 85 UP STEROID (P050023/S084) | Biotronik, Inc. | 2015-07-17 |
| CAPESUREFIX LEAD, CAPSUREFIX NOVUS LEAD,VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S133) | Medtronic, Inc. | 2015-07-17 |
| SLX 58/11-BP, SLX 58/13-BP,SLX 58/14-BP,SLX 58/15-BP,SLX 58/17-BP,SLX 65/11-BP,SLX 65/13-BP,SLX 65/14-BP,SLX 65/15-BP,SL (P950037/S149) | Biotronik, Inc. | 2015-07-17 |
| KAINOX VCS,PROTEGO SD (60/16)(65/16),(65/18)(75/18), PROTEGO TD (65/16)(65/18)(75/18), PROTEGO S (60/65/75)PROTEGO T 65 (P980023/S065) | Biotronik, Inc. | 2015-07-17 |
| CAPSUREFIX MRI LEAD (P090013/S188) | Medtronic, Inc. | 2015-07-17 |
| PROTEGO (S/SD/T/TD) ICD LEAD (P980023/S071) | Biotronik, Inc. | 2015-07-17 |
| COROX OTW 75-BP, COROX OTW 85-BP,COROX OTW-S 75-BP,COROX OTW-S 85-BP,COROX OTW-L 75-BP,COROX OTW-L 85-BP (P070008/S061) | Biotronik, Inc. | 2015-07-17 |
| SPRINT QUATTRO LEAD (P920015/S157) | Medtronic, Inc. | 2015-07-17 |
| EASYTRAK 2 CORONARY SINUS PACING LEADS, EASYTRAK 3 CORONARY SINUS PACING LEADS, ACUITY SPIRAL CORONARY SINUS PACING LEAD (P010012/S391) | Boston Scientific Corp | 2015-07-16 |
| VALITUDE, VALITUDE X4 CRT-PS (P030005/S124) | Guidant Corp. | 2015-07-16 |
| CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S135) | Medtronic, Inc. | 2015-07-16 |
| ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS (N970003/S177) | Boston Scientific Corp | 2015-07-16 |
| ENDOTAK RELIANCE G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS, ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS (P910073/S130) | Boston Scientific | 2015-07-16 |
| FINELINE 2 PACING LEADS (P960004/S070) | Boston Scientific | 2015-07-16 |
| ACUITY STEERABLE CORONARY SINUS PACING LEADS (P050046/S026) | Guidant Corp. | 2015-07-16 |
| FLEXTEND PACING LEADS (P960006/S044) | Boston Scientific | 2015-07-16 |
| CAPSUREFIX MRI LEAD (P090013/S191) | Medtronic, Inc. | 2015-07-16 |
| FLUENCY PLUS ENDOVASCULAR STENT GRAFT (P130029/S003) | Bard Peripheral Vascular, Inc. | 2015-07-15 |
| MELODY TRANSCATHETER PULMONARY VALVE (P140017/S001) | Medtronic, Inc. | 2015-07-15 |
| CAPSUREFIX MRI LEAD (P090013/S189) | Medtronic, Inc. | 2015-07-14 |
| COREVALVE ENVOLUT R SYSTEM (P130021/S015) | Medtronic, Inc. | 2015-07-14 |
| CAPSUREFIX NOVUS LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, VITATRON CRYSTALLINE ACTIVE FIX (P930039/S134) | Medtronic, Inc. | 2015-07-14 |
| ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS (P910023/S357) | ABBOTT MEDICAL | 2015-07-13 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS (P030054/S286) | ABBOTT MEDICAL | 2015-07-13 |
| TUNNELING TOOL (P920015/S158) | Medtronic, Inc. | 2015-07-13 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S257) | ABBOTT MEDICAL | 2015-07-13 |
| FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S135) | ABBOTT MEDICAL | 2015-07-13 |
| ADAPTA, VERSA, SENSIA, RELIA, IPG (P980035/S428) | Medtronic, Inc. | 2015-07-11 |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S002) | ABBOTT MEDICAL | 2015-07-10 |
| SAFIRE DUO AND COOL PATH DUO ABLATION CATHETERS (P110016/S014) | ABBOTT MEDICAL | 2015-07-09 |
| THERAPY DUAL ABLATION CATHETER, SAFIRE TX ABLATION CATHETER (P040042/S029) | Irvine Biomedical,Inc.(Ibi) | 2015-07-09 |
| THERAPY COOL PATH ABLATION CATHETER (P060019/S030) | Irvine Biomedical, Inc. | 2015-07-09 |
| TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM (P070027/S041) | Medtronic Vascular | 2015-07-09 |
| COMPLETE SE VASCULAR STENT SYSTEM (P110040/S006) | Medtronic Vascular | 2015-07-09 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S080) | Medtronic, Ireland | 2015-07-09 |
| FLEXABILITY ABLATION CATHETER (BI AND UNI DIRECTIONAL) (P110016/S018) | ABBOTT MEDICAL | 2015-07-09 |
| COREVALVE SYSTEM (P130021/S012) | Medtronic, Inc. | 2015-07-09 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S050) | Medtronic Vascular | 2015-07-09 |
| THERAPY ABLATION CATHETER (P040014/S024) | Irvine Biomedical, Inc. | 2015-07-09 |
| IN.PACT ADMIRAL DCB (P140010/S005) | Medtronic, Inc. | 2015-07-09 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S118) | W. L. Gore & Associates, Inc. | 2015-07-09 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S061) | Medtronic | 2015-07-09 |
| VALIANT THORACIC STENTGRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S020) | Medtronic Vascular | 2015-07-09 |
| LIVEWIRE TC ABLATION CATHETER, SAFIRE ABLATION CATHETER (P960016/S050) | St Jude Medical | 2015-07-09 |
| ENDURANT AND ENDURANT II STENT SYSTEM (P100021/S046) | Medtronic Vascular | 2015-07-09 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CORONARY STENT SYSTEM (P110010/S113) | Boston Scientific Corp | 2015-07-09 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S015) | Medtronic Vascular | 2015-07-09 |
| ASSURANT COLBALT ILIAC BALLON-EXPANDABLE STENT SYSTEM (P110011/S010) | Medtronic, Ireland | 2015-07-09 |
| ROTAWIRE GUIDEWIRE WITH WIRECLIP TORQUER (P900056/S149) | Boston Scientific Corp | 2015-07-09 |
| IMPELLA 2.5 SYSTEM (P140003/S003) | Abiomed, Inc. | 2015-07-08 |
| VASCADE VASCULAR CLOSURE SYSTEM (VCS) (P120016/S015) | Cardiva Medical, Inc. | 2015-07-08 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S063) | Medtronic | 2015-07-08 |
| SPRINT QUATTRO LEAD (P920015/S156) | Medtronic, Inc. | 2015-07-07 |
| PROTEGO SD 60/16, PROTEGO SD 65/16, PROTEGO SD 65/18, PROTEGO SD 75/18, PROTEGO TD 65/16, PROTEGO TD 65/18, PROTEGO TD (P980023/S069) | Biotronik, Inc. | 2015-07-07 |
| PROMUS ELEMENT PLUS EVEROLIMUS - ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S099) | Boston Scientific Corp | 2015-07-07 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS) (P130005/S005) | Cardiovascular Systems, Inc. | 2015-07-07 |
| EVIA HF,EVIA HF-T, ENTOVIS HF,ENTOVIS HF-T (P070008/S067) | Biotronik, Inc. | 2015-07-07 |
| EVIA DR, EVIA DR-T, EVIA SR, EVIA SR-T, ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, ESTELLA DR, ESTELLA DR-T, ES (P950037/S157) | Biotronik, Inc. | 2015-07-07 |
| FLEXABILITY ABLATION CATHETER (P110016/S016) | ABBOTT MEDICAL | 2015-07-02 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S060) | Medtronic | 2015-07-02 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S117) | W. L. Gore & Associates, Inc. | 2015-07-02 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S062) | Medtronic | 2015-07-02 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S112) | Boston Scientific Corp | 2015-07-01 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S121) | Boston Scientific Corp | 2015-07-01 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S014) | Boston Scientific Corp | 2015-07-01 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S015) | Boston Scientific Corp | 2015-07-01 |
| PROMUS ELEMENT PLUS EVEROLIMUS ELUTING STENT SYSTEM, PROMUS PREMIER EVEROLIMUS ELUTING STENT SYSTEM (P110010/S111) | Boston Scientific Corp | 2015-07-01 |
| ION PACLITAXEL ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S120) | Boston Scientific Corp | 2015-07-01 |
| ACUITY STEERABLE LEAD (P050046/S025) | Guidant Corp. | 2015-06-30 |
| EASYTRAK 2 AND EASYTRAK 3 CORONARY VENOUS STEROID ELUTING BIPOLAR PACE/SENSE LEAD,ACUITY SPIRAL LEAD (P010012/S390) | Boston Scientific Corp | 2015-06-30 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S062) | Zoll Manufacturing Corporation | 2015-06-30 |
| LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S002) | Lutonix | 2015-06-30 |
| FINELINE II STEROX ENDOCARDIAL PACING LEAD (P960004/S069) | Boston Scientific | 2015-06-30 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S045) | Medtronic | 2015-06-29 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S274) | Medtronic, Inc. | 2015-06-29 |
| MEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEAD (P080006/S081) | Medtronic, Inc. | 2015-06-29 |
| BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD, VIVA S/XT CRT-D'S (P010031/S502) | Medtronic Cardiac Rhythm Disease Management | 2015-06-29 |
| ADVISA DR IPG, ADVISA DR MRI IPG AND ADVISA SR MRI IPG (P980035/S426) | Medtronic, Inc. | 2015-06-29 |
| EVERA S DR/VR, EVERA XT DR/VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II DR/VR ICD'S (P980016/S539) | Medtronic Cardiac Rhythm Disease Management | 2015-06-29 |
| ADVISA SR MRI (P980035/S427) | Medtronic, Inc. | 2015-06-27 |
| RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMS (P110013/S052) | Medtronic Vascular | 2015-06-26 |
| PROMUS ELEMENT PLUS/PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S109) | Boston Scientific Corp | 2015-06-26 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S118) | Boston Scientific Corp | 2015-06-26 |
| DIAMONDBACK 360 CORONARY ORIBITAL ATHERECTOMY SYSTEM (OAS) (P130005/S008) | Cardiovascular Systems, Inc. | 2015-06-25 |
| ATTAIN ABILITY LEAD (P080006/S082) | Medtronic, Inc. | 2015-06-25 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS) (P130005/S009) | Cardiovascular Systems, Inc. | 2015-06-25 |
| VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM (P100040/S022) | Medtronic Vascular | 2015-06-25 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S015) | Medtronic Vascular, Inc. | 2015-06-24 |
| IN-PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S006) | Medtronic, Inc. | 2015-06-24 |
| MISAGO RX SELF-EXPANDING PERIPHERAL STENT (P140002/S001) | Terumo Medical Corporation | 2015-06-24 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S108) | Boston Scientific Corp | 2015-06-23 |
| INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER (P020025/S074) | Boston Scientific | 2015-06-23 |