| BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD C, S AND XT, VIVA S, VIVA XT CRT-D (P010031/S522) | Medtronic Cardiac Rhythm Disease Management | 2016-02-05 |
| MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR (P890003/S344) | Medtronic, Inc. | 2016-02-05 |
| EMBLEM (SUBCUTANEOUS ICD DEVICES) (P110042/S057) | Boston Scientific Corporation | 2016-02-05 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIMUM CORONARY STENT SYSTEM MONORAIL & OVER-THE-WIRE. (P150003/S004) | Boston Scientific Corporation | 2016-02-04 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S027) | W. L. Gore & Associates, Inc. | 2016-02-04 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S088) | W. L. Gore & Associates, Inc. | 2016-02-04 |
| VALITUDE , VALITUDE X4 CRT-PS (P030005/S132) | Guidant Corp. | 2016-02-03 |
| ESSENTIO; PROPONENT; ACCOLADE ; ALTRUA 2 PACEMAKERS (N970003/S185) | Boston Scientific Corp | 2016-02-03 |
| SPRINT QUATTRO LEADS (P920015/S171) | Medtronic, Inc. | 2016-02-02 |
| ATTAIN ABILITY MRI , PLUS MRI,STRAIGHT MRI SURESCAN; ATTAIN PERFORMA MRI, STRAIGHT ANS S MRI SURESCAN (P080006/S085) | Medtronic, Inc. | 2016-02-01 |
| CAPSUREFIX NOVUS MRI SURESCAN (P930039/S140) | Medtronic, Inc. | 2016-02-01 |
| SPRINT QUATTRO SECURE S MRI SURESCAN ; SPRINT QUATTRO SECURE MRI SURESCAN (P920015/S163) | Medtronic, Inc. | 2016-02-01 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S080) | W. L. Gore & Associates, Inc. | 2016-02-01 |
| AMPLIA MRI/AMPLIA MRI QUAD CRT-D SURESCAN; COMPIA MRI/COMPIA MRI QUAD CRT-D SURESCAN (P010031/S513) | Medtronic Cardiac Rhythm Disease Management | 2016-02-01 |
| TACTICATH QUARTZ SET (P130026/S014) | St Jude Medical | 2016-02-01 |
| CAPSUREFIX MRI SURESCAN (P090013/S202) | Medtronic, Inc. | 2016-02-01 |
| SPRINT QUATTRO (P920015/S172) | Medtronic, Inc. | 2016-02-01 |
| CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS MONITOR (P890003/S338) | Medtronic, Inc. | 2016-02-01 |
| MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (P040044/S069) | Cordis US Corporation | 2016-01-31 |
| ASSURITY AND ENDURITY CORE FAMILY OF PACEMAKERS (P880086/S267) | ABBOTT MEDICAL | 2016-01-30 |
| LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S006) | Lutonix | 2016-01-29 |
| PROTEGO SD 60/16,PROTEGO SD 65/16,PROTEGO SD 75/18,PROTEGO S 60,PROTEGO S 65,PROTEGO S 75,PROTEGO T 65,PROTEGO TD 65/16, (P980023/S066) | Biotronik, Inc. | 2016-01-28 |
| COROX OTW 75 UP STEROID, COROX OTW 85 UP STEROID (P050023/S089) | Biotronik, Inc. | 2016-01-28 |
| CELERITY 2D 75, CELERITY 2D 85,CELERITY 3D 75, CELERITY 3D 85, CELERITY PILOT 75, CELERITY PILOT 85, COROX OTW-L 75-BP, (P070008/S064) | Biotronik, Inc. | 2016-01-28 |
| SELOX SR 45,SELOX SR 53,SELOX SR 60,SELOX JT 45,SELOX JT 53,SELOX ST 53,SELOX ST 60,SETROX S 45,SETROX S 53,SETROX S 60, (P950037/S153) | Biotronik, Inc. | 2016-01-28 |
| FREEZOR CARDIAC CRYOABLATION SYSTEM (P020045/S072) | Medtronic Cryocath, LP | 2016-01-27 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S068) | Zoll Manufacturing Corporation | 2016-01-26 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S003) | Edwards Lifesciences, LLC | 2016-01-26 |
| SELECTSECURE LEAD (P030036/S083) | Medtronic Cardiac Rhythm Disease Management | 2016-01-25 |
| EVERA MRI ICD, EVERA S DR ICD, EVERA S VR ICD. EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA X (P980016/S564) | Medtronic Cardiac Rhythm Disease Management | 2016-01-25 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S067) | Medtronic, Inc. | 2016-01-25 |
| EPICARDIAL PATCH LEAD (P900061/S138) | Medtronic Cardiac Rhythm Disease Management | 2016-01-25 |
| ADAPTA, VERSA, SENSIA IPG, ADAPTA DR IPG, ADVISA DR MRI IPG, ADVISA DR MRI IPG, RELIA IPG, (P980035/S451) | Medtronic, Inc. | 2016-01-25 |
| ATTAIN STARFIX LEAD (P060039/S069) | Medtronic, Inc. | 2016-01-25 |
| ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD, CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S290) | Medtronic, Inc. | 2016-01-25 |
| ATTAIN ABILITY LEAD, ATTAIN PERFORMA LEAD, ATTAIN PERFORMA LEAD (P080006/S087) | Medtronic, Inc. | 2016-01-25 |
| CAPSURE SP NOVUS LEAD; CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD. (P850089/S116) | Medtronic Cardiac Rhythm Disease Management | 2016-01-25 |
| CAPSURE VDD 2 LEAD. VITATRON BRILLIANT S+ VDD LEAD, VITATRON BRILLIANT S+VDD LEAD (P890003/S348) | Medtronic, Inc. | 2016-01-25 |
| TRANSVENE CS/SVC LEAD (P980050/S103) | Medtronic, Inc. | 2016-01-25 |
| CAPSURE SENSE LEAD, CAPSURE SP LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+LEAD (P830061/S126) | Medtronic Cardiac Rhythm Disease Management | 2016-01-25 |
| SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD, HV SPLITTER/ADAPTOR KIT (P920015/S170) | Medtronic, Inc. | 2016-01-25 |
| IMPELLA 2.5 SYSTEM (P140003/S007) | Abiomed, Inc. | 2016-01-25 |
| COREVALVE EVOLUT BIOPROSTHESIS, CORE VALVE BIOPROSTHESIS, ACCUTRAK DELIVERY CATHETER SYSTEM, GEN 3 & GEN4 COMPRESSION LO (P130021/S018) | Medtronic, Inc. | 2016-01-25 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D , PROTECTA CRT-D, PROT (P010031/S525) | Medtronic Cardiac Rhythm Disease Management | 2016-01-25 |
| CAPSUREFIX MRI LEAD, REVO MRI SURESCAN IPG (P090013/S213) | Medtronic, Inc. | 2016-01-25 |
| MYOCARDIAL PACING LEAD (P120017/S003) | Medtronic, Inc. | 2016-01-25 |
| CAPSUREFIX LEAD. CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITRATRON CRYSTALLINE ACTIVE FIXATION LEAD, VITATRON CRYSTALLINE (P930039/S146) | Medtronic, Inc. | 2016-01-25 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S011) | Abbott Vascular (Idef Technologies Inc) | 2016-01-22 |
| THORATEC HEARTMATE II VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P060040/S049) | ABBOTT MEDICAL | 2016-01-21 |
| SELECTSECURE LEAD (P030036/S084) | Medtronic Cardiac Rhythm Disease Management | 2016-01-21 |
| THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P870072/S061) | Thoratec Laboratories Corp. | 2016-01-21 |
| RF MARINR 5F SC, RF MARINR 5F SCXL, RF MARINR 5F SCXS, RF MARINR 5F SCXXL (P930029/S054) | Medtronic, Inc. | 2016-01-21 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE (P130005/S010) | Cardiovascular Systems, Inc. | 2016-01-21 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION (P930039/S147) | Medtronic, Inc. | 2016-01-21 |
| CAPSUREFIX MRI LEAD (P090013/S214) | Medtronic, Inc. | 2016-01-21 |
| EPICARDIAL PATCH LEAD (P900061/S139) | Medtronic Cardiac Rhythm Disease Management | 2016-01-21 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S021) | LeMaitre Vascular, Inc. | 2016-01-19 |
| SPRINT QUATTRO SECURE S MRI SURESCAN LEAD, SPRINT QUATTRO SECURE MRI SURESCAN LEAD (P920015/S164) | Medtronic, Inc. | 2016-01-19 |
| VISIA AF VR , S VR, AFMRI VR SURESCAN, PROGRAMMER SOFTWARE, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980016/S551) | Medtronic Cardiac Rhythm Disease Management | 2016-01-19 |
| CARELINK MONITOR , CARDIOSIGHT READER, CARELINK EXPRESS MONITOR (P890003/S339) | Medtronic, Inc. | 2016-01-19 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S071) | Medtronic | 2016-01-15 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S064) | Medtronic | 2016-01-15 |
| FREEZOR CARDIAC CRYOABLATION SYSTEM (P020045/S071) | Medtronic Cryocath, LP | 2016-01-14 |
| CAPSURE SP NOVUS LEAD; CAPSURE Z NOVUS LEAD; VITATRON EXCELLENCE SS+LEAD; VITATRON IMPULSE II LEAD (P850089/S115) | Medtronic Cardiac Rhythm Disease Management | 2016-01-13 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S066) | Medtronic, Inc. | 2016-01-13 |
| MYOCARDIAL PACING LEAD (P120017/S002) | Medtronic, Inc. | 2016-01-13 |
| ATTAIN STARFIX LEAD (P060039/S068) | Medtronic, Inc. | 2016-01-13 |
| CAPSURE VDD 2 LEAD; VITATRON BRILLIANT S+VDD LEAD;VITATRON BRILLAIANT S+VDD LEAD (P890003/S347) | Medtronic, Inc. | 2016-01-13 |
| EVERA MRI ,EVERA, MARQUIS, SECURA, MAXIMO II, INTRINSIC, PROTECTA, PROTECTA XT, VIRTUOSO (P980016/S560) | Medtronic Cardiac Rhythm Disease Management | 2016-01-13 |
| MEDTRONIC CARELINK HOME MONITOR 2490C (P890003/S343) | Medtronic, Inc. | 2016-01-13 |
| BRAVA, BRAVA QUAD, CONCERTO, CONCERTO II, CONSULTA, MAXIMO II,PROTECTA, PROTECTA XT, VIVA QUAD, VIVA S, VIVA XT (P010031/S521) | Medtronic Cardiac Rhythm Disease Management | 2016-01-13 |
| CAPSUREFIX MRI LEAD (P090013/S212) | Medtronic, Inc. | 2016-01-13 |
| CAPSUREFIX LEAD; CAPSUREFIX NOVUS LEAD; SUREFIX LEAD;VITATRON CRYSTALLINE ACTIVE FIXATION LEAD; VITATRON CRYSTALLINE ACT (P930039/S145) | Medtronic, Inc. | 2016-01-13 |
| ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD (P010015/S289) | Medtronic, Inc. | 2016-01-13 |
| Crown PRT Aortic Pericardial Heart Valve with PR Treatment (P060038/S026) | Corcym Canada Corp | 2016-01-13 |
| CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD; VITATRON EXCELLENCE LEAD PS+LEAD (P830061/S125) | Medtronic Cardiac Rhythm Disease Management | 2016-01-13 |
| TRANSVENE CS/SVC LEAD (P980050/S102) | Medtronic, Inc. | 2016-01-13 |
| SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD; TRANSVENE CS/SVC LEAD (P920015/S169) | Medtronic, Inc. | 2016-01-13 |
| SELECTSECURE LEAD (P030036/S081) | Medtronic Cardiac Rhythm Disease Management | 2016-01-13 |
| ATTAIN ABILITY LEAD, ATTAIN PERFORMA LEADS (P080006/S086) | Medtronic, Inc. | 2016-01-13 |
| FREEZOR MAX CARDIAC CRYOBLATION CATHETERS (P100010/S052) | Medtronic Cryocath, LP | 2016-01-12 |
| FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CRYOABLATION DEVICE (P020045/S070) | Medtronic Cryocath, LP | 2016-01-12 |
| MEDTRONIC MODEL 5019 HV SPLITTER/ADAPTOR (P920015/S168) | Medtronic, Inc. | 2016-01-11 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S047) | ABBOTT MEDICAL | 2016-01-11 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S079) | W. L. Gore & Associates, Inc. | 2016-01-08 |
| OPTISURE FAMILY OF HIGH VOLTAGE LEADS (P950022/S090) | ABBOTT MEDICAL | 2016-01-08 |
| PERCEVAL SUTURELESS HEART VALVE (P150011) | Corcym S.r.l. | 2016-01-08 |
| NOVAFLEX+ DELIVERY SYSTEM, EDWARDS EXPANDABLE INTRODUCER SHEATH SET (P130009/S044) | Edwards Lifesciences, LLC | 2016-01-08 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S051) | ABBOTT MEDICAL | 2016-01-08 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S037) | Syncardia Systems, LLC | 2016-01-07 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S047) | W. L. Gore & Associates, Inc. | 2016-01-07 |
| ON-X PROSTHETIC HEART VALVE (P000037/S044) | On-X Life Technologies, Inc. | 2016-01-06 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S014) | Cook Ireland, Ltd. | 2016-01-06 |
| IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S012) | Medtronic, Inc. | 2016-01-06 |
| SPRINT QUATTRO MODEL 6946M LEAD (P920015/S155) | Medtronic, Inc. | 2016-01-05 |
| ADAPTA, VERSA, SENSIA IPG (P980035/S449) | Medtronic, Inc. | 2016-01-05 |
| EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (26MM SIZE ONLY) (P140031/S004) | Edwards Lifesciences, LLC | 2016-01-04 |
| ASSURITY, ASSURITY+, ENDURITY, ENDURITY CORE FAMILY OF PACEMAKER DEVICES (P880086/S266) | ABBOTT MEDICAL | 2016-01-04 |
| CORDIS PRECISE NITINOL STENT SYSTEMS (P030047/S030) | Cordis US Corporation | 2016-01-04 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S005) | Edwards Lifesciences, LLC | 2016-01-04 |