| ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM (P150023/S001) | Abbott Vascular, Inc. | 2016-10-07 |
| IN PACT ADMIRAL PACLITAXEL-COATED BALLOON CATHETER (P140010/S025) | Medtronic, Inc. | 2016-10-07 |
| FlexAbility Ablation Catheter (Bi-Directional) (P110016/S036) | ABBOTT MEDICAL | 2016-10-07 |
| CapSureFix Novus Lead; Vitatron Crystalline; Active Fixation Lead (P930039/S159) | Medtronic, Inc. | 2016-10-06 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S046) | Best Vascular, Inc. | 2016-10-06 |
| Attain Ability, Performa Lead 4298, (P080006/S099) | Medtronic, Inc. | 2016-10-06 |
| Attain Bipolar OTW Lead (P010015/S309) | Medtronic, Inc. | 2016-10-06 |
| HV splitter/adaptor kit; Sprint Quattro Lead (P920015/S184) | Medtronic, Inc. | 2016-10-06 |
| ATTAIN STARFIX MODEL 4195 LEAD (P060039/S073) | Medtronic, Inc. | 2016-10-06 |
| CapSure Sense, SP Novus Lead: Vitatron Crystalline, Excellence PS+ Lead; (P830061/S135) | Medtronic Cardiac Rhythm Disease Management | 2016-10-06 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S015) | Abbott Vascular (Idef Technologies Inc) | 2016-10-06 |
| ATRICURE SYNERGY ABLATION SYSTEM (P100046/S008) | AtriCure, Inc. | 2016-10-05 |
| D-Stat Flowable hemostat (P990037/S034) | Vascular Solutions, Inc. | 2016-10-05 |
| GORE TIGRIS VASCULAR STENT (P160004/S001) | W. L. Gore & Associates, Inc. | 2016-10-05 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S050) | W. L. Gore & Associates, Inc. | 2016-10-05 |
| THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (P060040/S058) | ABBOTT MEDICAL | 2016-10-05 |
| Amplia, Brava, Compia, Concerto II. Consulta, Maximo II, Protecta, Protecta XT, Viva S,XT, Quad CRT-D (P010031/S561) | Medtronic Cardiac Rhythm Disease Management | 2016-10-04 |
| REPLY/ESPRIT PACEMAKER IMPLANTABLE DEVICES (P980049/S118) | MicroPort CRM USA, Inc. | 2016-10-04 |
| Essentio, Proponent and Accolade MRI Pacemakers (P150012/S013) | Boston Scientific | 2016-10-04 |
| Evera S, Maximo II, Protecta, Secura,Quad XT CRT-D; Virtuoso II, Visia AF, MRI VR ICD, (P980016/S601) | Medtronic Cardiac Rhythm Disease Management | 2016-10-04 |
| Permanent defibrillator electrodes (P980023/S078) | Biotronik, Inc. | 2016-10-03 |
| ADVANTIO; INGENIO; VITALIO; FORMIO; ESSENTIO; PROPONENT; ACCOLADE; ALTRUA 2 PACEMAKERS. (N970003/S194) | Boston Scientific Corp | 2016-09-29 |
| Patient Cable (P820003/S136) | Medtronic Cardiac Rhythm Disease Management | 2016-09-29 |
| ORIGEN; INOGEN; DYNAGEN; PUNCTUA; ENERGEN; INCEPTA CRT-Ds (P010012/S432) | Boston Scientific Corp | 2016-09-29 |
| Patient Magnet (P900061/S141) | Medtronic Cardiac Rhythm Disease Management | 2016-09-29 |
| RF ENHANCR II (P930029/S055) | Medtronic, Inc. | 2016-09-29 |
| ORIGEN; INOGEN; DYNAGEN; PUNCTUA; ENERGEN; INCEPTA ICDS (P960040/S380) | Boston Scientific | 2016-09-29 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S133) | Boston Scientific Corp | 2016-09-29 |
| EMBLEM; EMBLEM MRI (S-ICD) (P110042/S063) | Boston Scientific Corporation | 2016-09-29 |
| ESSENTIO MRI; PROPONENT MRI; ACCOLADE MRI Pacemakers (P150012/S015) | Boston Scientific | 2016-09-29 |
| Patient Magnet (P980016/S599) | Medtronic Cardiac Rhythm Disease Management | 2016-09-29 |
| VALITUDE; INVIVE CRT-Ps (P030005/S142) | Guidant Corp. | 2016-09-29 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S020) | Boston Scientific Corporation | 2016-09-29 |
| OVATION ABDOMINAL STENT GRAFT SYSTEM (P120006/S024) | Endologix, LLC | 2016-09-29 |
| Analyzer Adaptors, Cable, Patient Cable; ECG Cable, Output Adaptor (P890003/S364) | Medtronic, Inc. | 2016-09-29 |
| ENDOTAK RELIANCE 4-SITE, Defibrillation Lead Family ,Active Fixation Models (New): 0272, 0273. Passive Fixation Models ( (P910073/S138) | Boston Scientific | 2016-09-29 |
| HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S060) | ABBOTT MEDICAL | 2016-09-29 |
| ATTAIN ABILITY LEAD; ATTAIN PERFORMA LEAD (P080006/S098) | Medtronic, Inc. | 2016-09-28 |
| CAPSURE SENSE LEAD; CAPSURE SP NOVUS LEAD; VITATRON CYRSTALLINE LEAD; VITATRON EXCELLENCE PS+ LEAD (P830061/S134) | Medtronic Cardiac Rhythm Disease Management | 2016-09-28 |
| SPRINT QUATTRO/SUBCUTANEOUS/TRANSVENE CS/SVC LEADS (P920015/S183) | Medtronic, Inc. | 2016-09-28 |
| CAPSURE VDD 2 LEAD, VITATRON BRILLIANT S+ VVD LEAD (P890003/S363) | Medtronic, Inc. | 2016-09-28 |
| TRANSVENE CS/SVC LEAD (P980050/S106) | Medtronic, Inc. | 2016-09-28 |
| INTEGRITY CORONARY STENT SYSTEM (P030009/S090) | Medtronic, Ireland | 2016-09-28 |
| PALMAZ BALLOON EXPANDABLE STENT (P890017/S018) | Cordis US Corporation | 2016-09-28 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S076) | Medtronic Vascular | 2016-09-28 |
| ATTAIN BIPOLAR OTW AND OTW LV LEAD (P010015/S307) | Medtronic, Inc. | 2016-09-28 |
| CAPSUREFIX MRI LEAD (P090013/S234) | Medtronic, Inc. | 2016-09-28 |
| ATTAIN STARFIX LEAD (P060039/S072) | Medtronic, Inc. | 2016-09-28 |
| CAPSURE SP NOVUS/CAPSURE SP Z/CAPSURE Z NOVUS LEADS, VITATRON IMPULSE II LEAD (P850089/S119) | Medtronic Cardiac Rhythm Disease Management | 2016-09-28 |
| ON-X PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS (P000037/S047) | On-X Life Technologies, Inc. | 2016-09-28 |
| CAPSUREFIX,CAPSUREFIX NOVUS, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S158) | Medtronic, Inc. | 2016-09-28 |
| Platinum VR/DR ICDS,Paradym RF VR/ RF DR CRT-Ds, Intensia VR, Intensia DR (P980049/S117) | MicroPort CRM USA, Inc. | 2016-09-27 |
| Platinium, Paradym RF, RF VR, RF DR, Intensia CRT-Ds (P060027/S083) | MicroPort CRM USA, Inc. | 2016-09-27 |
| BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S004) | Boston Scientific Corp | 2016-09-27 |
| Allure, Allure Quadra, Quadra Allure MP (P030035/S149) | ABBOTT MEDICAL | 2016-09-27 |
| Reply Sr, Reply DR, Esprit SR, Esprit DR Pacemakers (P950029/S111) | MicroPort CRM USA, Inc. | 2016-09-27 |
| WOLVERINE CORONARY CUTTING BALLOON MONORAIL, OVER-THE WIRE. (P950020/S075) | Boston Scientific Corp | 2016-09-27 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S023) | Boston Scientific Corp | 2016-09-27 |
| MYOPORE SUTURELESS MYOCARDIAL PACING LEAD (P130012/S002) | Great Batch Medical | 2016-09-27 |
| Assurity, Assurity+, Endurity, Endurity Core (P880086/S275) | ABBOTT MEDICAL | 2016-09-27 |
| XIENCE XPEDITION & ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S086) | Abbott Vascular | 2016-09-27 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S030) | Boston Scientific Corp | 2016-09-27 |
| TENDRIL ST, STS AND OPTISENSE LV LEADS (P960013/S083) | ABBOTT MEDICAL | 2016-09-26 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S023) | Edwards Lifesciences, LLC | 2016-09-25 |
| PERCEVAL SUTURELESS HEART VALVE (P150011/S005) | Corcym S.r.l. | 2016-09-23 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S029) | Corcym Canada Corp | 2016-09-23 |
| MYNXGRIP AND MYNX ACE VASCULAR CLOSURE DEVICE (P040044/S074) | Cordis US Corporation | 2016-09-23 |
| SOLO SMART STENTLESS HEART VALVE (P130011/S005) | Corcym Canada Corp | 2016-09-23 |
| Adapta, Versa, Sensia IPG AND Relia IPG (P980035/S470) | Medtronic, Inc. | 2016-09-22 |
| GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S030) | W. L. Gore & Associates, Inc. | 2016-09-22 |
| Gore VIABAHN ENDOPROSTHESIS (P040037/S091) | W. L. Gore & Associates, Inc. | 2016-09-22 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S136) | W. L. Gore & Associates, Inc. | 2016-09-22 |
| THERMOCOOL SMART TOUCH BI-DIRECTIONAL AND ELECTROPHYSIOLOGY (P040036/S057) | Biosense Webster, Inc. | 2016-09-21 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S032) | W. L. Gore & Associates, Inc. | 2016-09-21 |
| CELSIUS/DEFLECTABLE TIP ELECTROPHYSIOLOGY CATHETER (P950005/S062) | Biosense Webster, Inc. | 2016-09-21 |
| ICDs (Implantable Cardioverter Defibrillator) Platinium VR 1210, 1240; Platinium DR 1510, 1540. (P980049/S122) | MicroPort CRM USA, Inc. | 2016-09-21 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S045) | Syncardia Systems, LLC | 2016-09-21 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S093) | W. L. Gore & Associates, Inc. | 2016-09-21 |
| NAVISTAR DS ELECTROPHYSIOLOGY CATHETER (P010068/S052) | Biosense Webster, Inc. | 2016-09-21 |
| CapSureFix Novus Lead Model 4076 (P930039/S157) | Medtronic, Inc. | 2016-09-21 |
| NAVISTAR ELECTROPHYSIOLOGY CATHETER (P990025/S050) | Biosense Webster, Inc. | 2016-09-21 |
| CapSure Sense Lead Models 4074, 4574 (P830061/S133) | Medtronic Cardiac Rhythm Disease Management | 2016-09-21 |
| CRT-Ds (Cardiac Resynchronization Therapy Defibrillator),Platinium CRT-D 1711, 01741 (P060027/S087) | MicroPort CRM USA, Inc. | 2016-09-21 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S049) | W. L. Gore & Associates, Inc. | 2016-09-21 |
| EZ STEER THERMOCOOL NAVIGATION AND THERMOCOOL BI-DIRECTIONAL CATHETER;THERMOCOOL SF/SF NAV BI-DIRECTIONAL AND SF/SF NAV (P030031/S077) | Biosense Webster, Inc. | 2016-09-21 |
| THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL & UNI-DIRECTIONAL NAVIGATION CATHETER (P030031/S076) | Biosense Webster, Inc. | 2016-09-20 |
| Sprint Quattro Lead; Subcutaneous Lead (P920015/S182) | Medtronic, Inc. | 2016-09-20 |
| Attain Ability Lead, Attain Performa Lead (P080006/S097) | Medtronic, Inc. | 2016-09-20 |
| CapSure Fix Novus Lead; Vitatron Crystalline Active; Fixation Lead, ICF09, ICQ09B (P930039/S156) | Medtronic, Inc. | 2016-09-20 |
| Paradym VR, DR,Paradym RF VR, Paradym RF DR (ZL101),(ZL102),Intensia VR, Intensia DR,Platinium VR 1210, Platinium VR 124 (P980049/S120) | MicroPort CRM USA, Inc. | 2016-09-20 |
| Myocardial Pacing Lead (P120017/S005) | Medtronic, Inc. | 2016-09-20 |
| CapSure Sense Lead; Vitatron Crystalline Lead, ICM09 (P830061/S132) | Medtronic Cardiac Rhythm Disease Management | 2016-09-20 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S053) | Edwards Lifesciences, LLC | 2016-09-20 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S083) | Medtronic | 2016-09-20 |
| Paradym CRT-D; Paradym RF CRT-D (ZL101),(ZL102); Intensia CRT-D; Platinium CRT-D 1711,1741. (P060027/S085) | MicroPort CRM USA, Inc. | 2016-09-20 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S064) | Edwards Lifesciences, LLC | 2016-09-19 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S153) | Edwards Lifesciences, LLC | 2016-09-19 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S012) | Bolton Medical, Inc. | 2016-09-19 |
| MYOPORE SUTURELESS MYOCARDIAL PACING LEAD (P130012/S001) | Great Batch Medical | 2016-09-19 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S022) | Edwards Lifesciences, LLC | 2016-09-19 |