| ATTAIN BIPOLAR OTW AND OTE LV LEAD (P010015/S312) | Medtronic, Inc. | 2016-11-02 |
| Evera S DR,VR ICD; Evera XT DR, VR ICD (P980016/S605) | Medtronic Cardiac Rhythm Disease Management | 2016-11-02 |
| CAPSURE VDD 2/SERVICE KIT-PACEMAKER REPAIR KIT/VITATRON BRILLLIANT S+ VDD LEAD (P890003/S366) | Medtronic, Inc. | 2016-11-02 |
| END CAP/UPSIZING SLEEVE (P900061/S143) | Medtronic Cardiac Rhythm Disease Management | 2016-11-02 |
| ATTAIN ABILITY/PERFORMA LEAD (P080006/S100) | Medtronic, Inc. | 2016-11-02 |
| ANCHORING SLEEVE KIT/SELECTSECURE LEAD (P030036/S087) | Medtronic Cardiac Rhythm Disease Management | 2016-11-02 |
| HEARTWARE VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S085) | Medtronic | 2016-11-02 |
| TRANSVENE CS/SVC LEAD (P980050/S107) | Medtronic, Inc. | 2016-11-02 |
| CAPSUREFIX/CAPSUREFIX NOVUS/VITATRON CRYSTALLINE ACTIVE FIXATION LEADS (P930039/S161) | Medtronic, Inc. | 2016-11-02 |
| CAPSURE SP NOVUS/CAPSURE SP Z/CAPSURE Z NOVUS/VITATRON IMPULSE II LEADS (P850089/S120) | Medtronic Cardiac Rhythm Disease Management | 2016-11-02 |
| ATTAIN STARFIX LEAD (P060039/S074) | Medtronic, Inc. | 2016-11-02 |
| Micra TPS MC1VR01 (P150033/S010) | Medtronic, Inc. | 2016-11-02 |
| Brava,Brava Quad CRT-D; Viva S, XT,Viva Quad S, XT CRT-D (P010031/S566) | Medtronic Cardiac Rhythm Disease Management | 2016-11-02 |
| CAPSUREFIX MRI LEAD (P090013/S238) | Medtronic, Inc. | 2016-11-02 |
| MYOCARDIAL PACING LEAD (P120017/S006) | Medtronic, Inc. | 2016-11-02 |
| WALLSTENT ENDOPROSTHESIS VENOUS (P980033/S047) | Boston Scientific Corporation | 2016-11-01 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S038) | Boston Scientific Corp | 2016-11-01 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) (P110042/S066) | Boston Scientific Corporation | 2016-11-01 |
| WALLSTENT ENDOPROSTHESIS TIPS (P930031/S058) | Boston Scientific Corp | 2016-11-01 |
| WALLSTENT ENDOPROSTHESIS ILIAC (P940019/S049) | Boston Scientific Scimed, Inc. | 2016-11-01 |
| INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S019) | Boston Scientific Corporation | 2016-11-01 |
| IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S018) | Medtronic, Inc. | 2016-10-31 |
| AMPLATZER PFO OCCLUDER (P120021) | ABBOTT MEDICAL | 2016-10-28 |
| NEW BRANSON ULTRASONIC WELDER GENII (P860057/S147) | Edwards Lifesciences, LLC | 2016-10-28 |
| LIFESTENT VASCULAR STENT SYSTEM (P070014/S052) | Bard Peripheral Vascular, Inc. | 2016-10-28 |
| The ThermoCool SmartTouch SF Uni-Directional & Bi-Directional Navigational Catheter (P030031/S078) | Biosense Webster, Inc. | 2016-10-27 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S012) | Cardiovascular Systems, Inc. | 2016-10-26 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S008) | Medtronic, Inc. | 2016-10-26 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S022) | Boston Scientific Corporation | 2016-10-26 |
| QuickFlex U (P030054/S310) | ABBOTT MEDICAL | 2016-10-26 |
| Medtronic CoreValve Evolut R XL system (P130021/S025) | Medtronic, Inc. | 2016-10-26 |
| CARELINK MONITOR MODEL 2490C, MODEL 24950; CARDIOSIGHT READER MODEL 2020A, CARELINK EXPRESS MONITOR 2020B, MODEL 2491 DD (P890003/S356) | Medtronic, Inc. | 2016-10-25 |
| CAPSURE SENSE MRI SURESCAN LEAD MODEL 4574 (P830061/S130) | Medtronic Cardiac Rhythm Disease Management | 2016-10-25 |
| CLARIA MRI CRT-D SURESCAN MODEL DTMA1D4; QUAD MODEL DTMA1QQ; MODEL DTMA1D1, MODEL DTMBIQ1, MODEL DTMB1Q1,MODEL DTMC1D1, (P010031/S550) | Medtronic Cardiac Rhythm Disease Management | 2016-10-25 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD; ATTAIN ABILITY PLUS MRI SURESCAN LEAD MODEL 4296; ATTAIN ABILITY STRAIGHT MRI (P080006/S093) | Medtronic, Inc. | 2016-10-25 |
| MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568 (P930039/S152) | Medtronic, Inc. | 2016-10-25 |
| CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI (P090013/S226) | Medtronic, Inc. | 2016-10-25 |
| GORE VIABAHN ENDOPROSTHESIS and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S094) | W. L. Gore & Associates, Inc. | 2016-10-25 |
| Gore CARDIOFORM Septal Occluder (P050006/S053) | W. L. Gore & Associates, Inc. | 2016-10-25 |
| SPRINT QUATTRO SECURE S MRI SURESCAN LEAD MODEL 6935M & 6935; SPRINT QUATTRO SECURE MRI SURESCAN LEAD MODEL 6947M & 6947 (P920015/S179) | Medtronic, Inc. | 2016-10-25 |
| Repy SR/DR & Esprit SR/DR Pacemakers (P950029/S112) | MicroPort CRM USA, Inc. | 2016-10-25 |
| GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S033) | W. L. Gore & Associates, Inc. | 2016-10-24 |
| Amplia MRI CRT-D & QUAD CRT-D, Brava CRT-D, Brava Quad CRT-D, Compia MRI CRT-D & MRI Quad CRT-D, Viva Quad S & XT CRT-D' (P010031/S564) | Medtronic Cardiac Rhythm Disease Management | 2016-10-24 |
| Adapta, Verds, Sensia IPG ; Advisa DR IPG; Advisa DR & SR MRI IPG; Relia IPG (P980035/S476) | Medtronic, Inc. | 2016-10-24 |
| Evera MRI, S DR, S VR, XT DR, XT VR ICD's; Visia AF MRI VR ICD & Visia AF VR ICD (P980016/S603) | Medtronic Cardiac Rhythm Disease Management | 2016-10-24 |
| Micra TPS (P150033/S007) | Medtronic, Inc. | 2016-10-24 |
| Consulta CRT0P, Syncra CRT-P, Viva CRT-P (P010015/S310) | Medtronic, Inc. | 2016-10-24 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S087) | W. L. Gore & Associates, Inc. | 2016-10-24 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S138) | W. L. Gore & Associates, Inc. | 2016-10-24 |
| Reno MRI SureScan IPG (P090013/S237) | Medtronic, Inc. | 2016-10-24 |
| Amplia MRI CRT-D & Quad CRT-D, Brava CRT-D & Quad CRT-D, Compia MRI CRT-D & Quad CRT-D, Concerto II CRT-D, Consulta CRT- (P010031/S562) | Medtronic Cardiac Rhythm Disease Management | 2016-10-24 |
| GORE CARDIOFORM Septal Occluder; (P050006/S054) | W. L. Gore & Associates, Inc. | 2016-10-24 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S051) | W. L. Gore & Associates, Inc. | 2016-10-24 |
| Evera MRI, S DR, S VR, XT DR, XT VR ICD'S; Maximo Ii ICD; Protecta ICD, XT ICD; Secura DR ICD, Secura ICD; Virtuoso II D (P980016/S602) | Medtronic Cardiac Rhythm Disease Management | 2016-10-24 |
| Reocor S, Reocor D (P950037/S168) | Biotronik, Inc. | 2016-10-21 |
| VENASEAL CLOSURE SYSTEM (P140018/S004) | Medtronic Vascular, Inc. | 2016-10-21 |
| IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S023) | Medtronic, Inc. | 2016-10-20 |
| Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis 3000, with ThermaFix tissue process 3000TFX,Ease Per (P860057/S152) | Edwards Lifesciences, LLC | 2016-10-20 |
| CARDIOMEMS HF SYSTEM (P100045/S011) | ABBOTT MEDICAL | 2016-10-19 |
| HANCOCK VALVED CONDUIT (P870078/S033) | Medtronic, Inc. | 2016-10-19 |
| CONSULTA/SYNCRA/VIVA CRT-Ps (P010015/S311) | Medtronic, Inc. | 2016-10-18 |
| ADAPTA/VERSA/SENSIA/ADVISA DR/ADVISA DR MRI/ADVISA SR MRI/RELIA IPGs (P980035/S477) | Medtronic, Inc. | 2016-10-18 |
| MAXIMO II/PROTECTA/PROTECTA VR/PROTECTA XT/SECURA DR/SECURA/VIRTUOSO II DR/VR ICDs (P980016/S604) | Medtronic Cardiac Rhythm Disease Management | 2016-10-18 |
| MISAGO RX SELF-EXPANDING PERIPHERAL STENT (P140002/S004) | Terumo Medical Corporation | 2016-10-18 |
| CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT CRT-Ds (P010031/S565) | Medtronic Cardiac Rhythm Disease Management | 2016-10-18 |
| MISAGO RX SELF-EXPANDING PERIPHERAL STENT (P140002/S003) | Terumo Medical Corporation | 2016-10-18 |
| MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015/S185) | Medtronic, Inc. | 2016-10-17 |
| MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM (P900061/S142) | Medtronic Cardiac Rhythm Disease Management | 2016-10-17 |
| CapSureFix Novus Lead 4076, 5076 (P930039/S160) | Medtronic, Inc. | 2016-10-16 |
| CapSureFix MRI Lead 5086MRI (P090013/S236) | Medtronic, Inc. | 2016-10-16 |
| MISAGO RX Self-expanding Peripheral Stent (P140002/S005) | Terumo Medical Corporation | 2016-10-14 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL (MR) (P150003/S021) | Boston Scientific Corporation | 2016-10-14 |
| SJM BIOCOR AND EPIC VALVES (P040021/S027) | ABBOTT MEDICAL | 2016-10-14 |
| LUTONIX DRUG COATED BALLOON PTA CATETER (P130024/S015) | Lutonix | 2016-10-14 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S134) | Boston Scientific Corp | 2016-10-14 |
| GORE CARDIOFORM SEPTAL OCCLUDER (P050006/S052) | W. L. Gore & Associates, Inc. | 2016-10-13 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S014) | Bolton Medical, Inc. | 2016-10-13 |
| LifeVest Wearable Defibrillator (P010030/S083) | Zoll Manufacturing Corporation | 2016-10-13 |
| SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S088) | Spectranetics Corp. | 2016-10-13 |
| CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DYNAGEN, INOGEN, ORIGEN, X4 CRT-D: (P010012/S434) | Boston Scientific Corp | 2016-10-13 |
| IMPLANTABLE CARDIOVETER DEFIBRILLATOR, DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA MINI, EL, ICD (P960040/S382) | Boston Scientific | 2016-10-13 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR DEVICE (S-ICD) SYSTEM EMBLEM (P110042/S065) | Boston Scientific Corporation | 2016-10-13 |
| CAPSURE SENSE MRI SURESCAN LEAD MODELS 4074 AND 4574. (P830061/S129) | Medtronic Cardiac Rhythm Disease Management | 2016-10-12 |
| WALLSTENT ENDOPROSTHESIS LLIAC (P940019/S048) | Boston Scientific Scimed, Inc. | 2016-10-12 |
| INVIVE, INTUA, INGENIO 2, VALITUDE, VALITUDE X4 CRT-P (P030005/S143) | Guidant Corp. | 2016-10-12 |
| CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI (P090013/S225) | Medtronic, Inc. | 2016-10-12 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S046) | Syncardia Systems, LLC | 2016-10-12 |
| DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4 NG3 CRT-D; INCEPTA, ENERGEN, PUNCTUA PROGENY CRT-D (P010012/S433) | Boston Scientific Corp | 2016-10-12 |
| EVERA MRI XT DR SURESCAN MODEL DDMB1D1, EVERA MRI XT VR SURESCAN MODEL DVMB1D1, EVERA MRI S DR SURESCAN MODEL DDMC3D1, E (P980016/S586) | Medtronic Cardiac Rhythm Disease Management | 2016-10-12 |
| ESSENTIO, PROPONENT, ACCOLADE PACEMAKER (P150012/S016) | Boston Scientific | 2016-10-12 |
| INGENIO 2, ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE, ALTRUA PACEMAKERS; ADVANTIO, INGENIO, VITALIO, FORMIO (IPG) (N970003/S195) | Boston Scientific Corp | 2016-10-12 |
| ORIGEN EL, INOGEN EL, DYNAGEN EL NG3 ICD;ORIGEN MINI, INOGEN MINI, DYNAGEN MINI NG2.5 ICD; INCEPTA, ENERGEN, PUNCTUA PRO (P960040/S381) | Boston Scientific | 2016-10-12 |
| WALLSTENT ENDOPROSTHESIS TIPS (P930031/S057) | Boston Scientific Corp | 2016-10-12 |
| WALLSTENT ENDOPROSTHESIS VENOUS (P980033/S046) | Boston Scientific Corporation | 2016-10-12 |
| EMBLEM AND EMBLEM MRI S-ICD SYSTEM (P110042/S064) | Boston Scientific Corporation | 2016-10-12 |
| CARELINK MONITOR MODELS 2490C AND 2491 DDMA, CARDIOSIGHT READER MODEL 2020A, CARELINK EXPRESS MONITOR 2020B, MYCARELINK (P890003/S354) | Medtronic, Inc. | 2016-10-12 |
| CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 (P930039/S151) | Medtronic, Inc. | 2016-10-12 |
| SPRINT QUATTRO SECURE S MRI SURESCAN LEAD MODEL 6935 (DF-1), SPRINT QUATTRO SECURE MRI SURESCAN LEAD MODEL 6947 (DF-1) (P920015/S178) | Medtronic, Inc. | 2016-10-12 |
| Rotablator Rotational Atherectomy System (P900056/S155) | Boston Scientific Corp | 2016-10-11 |
| ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM (P150023/S005) | Abbott Vascular, Inc. | 2016-10-07 |