| ELCA (P910001/S090) | Spectranetics Corp. | 2017-01-05 |
| PLEXA S 60, PLEXA SD 60/16, PLEXA PROMRI S 65, PLEXA PROMRI S 75, PLEXA PROMRI SD 65/16, PLEXA PROMRI SD 65/18, PLEXA PR (P980023/S075) | Biotronik, Inc. | 2017-01-05 |
| SLS II/GLIDELIGHT CATHETERS (P960042/S055) | Spectranetics (Philips) | 2017-01-05 |
| Misago RX Self-expanding Peripheral Stent (P140002/S006) | Terumo Medical Corporation | 2017-01-05 |
| ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM (P040012/S057) | Abbott Vascular | 2017-01-05 |
| ST JUDE MEDICAL TRIFECTA VALVE (P100029/S023) | ABBOTT MEDICAL | 2016-12-30 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S020) | Cook Ireland, Ltd. | 2016-12-28 |
| Blazer II, Blazer II HTD, Blazer Prime HTD (P920047/S095) | Boston Scientific Corp | 2016-12-23 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S058) | Abbott Vascular | 2016-12-23 |
| Blazer II XP; Blazer Prime XP (P020025/S093) | Boston Scientific | 2016-12-23 |
| CARDIOMEMS HF SYSTEM (P100045/S016) | ABBOTT MEDICAL | 2016-12-22 |
| IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM, NG2.5, DYNAGEN, INOGEN, ORIGEN MINI ICD's (P960040/S383) | Boston Scientific | 2016-12-22 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM OVER THE WIRE (OTW) (P130030/S034) | Boston Scientific Corp | 2016-12-21 |
| Adapta, Versa, Sensia IPG & Relia IPG (P980035/S478) | Medtronic, Inc. | 2016-12-21 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S141) | W. L. Gore & Associates, Inc. | 2016-12-21 |
| ACUITY X4 lead family shelf life (P010012/S437) | Boston Scientific Corp | 2016-12-21 |
| LifeVest Wearable Defibrillator (P010030/S084) | Zoll Manufacturing Corporation | 2016-12-21 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S140) | W. L. Gore & Associates, Inc. | 2016-12-20 |
| CAPSURE VDD 2 LEAD/ VITATRON BRILLIANT S+VDD LEAD (P890003/S370) | Medtronic, Inc. | 2016-12-19 |
| AMPLIA MRI CRT-D & QUAD CRT-D; BRAVA CRT-D & QUAD CRT-D; CLARIA MRI CRT-D & QUAD CRT-D; COMPIA MRI CRT-D & QUAD CRT-D ; (P010031/S574) | Medtronic Cardiac Rhythm Disease Management | 2016-12-19 |
| CAPSURE SENSE LEAD /SP LEAD / CAPSURE SP NOVUS LEAD/ VITATRON CRYSTALLINE LEAD/ VITATRON EXCELLENCE PS + LEAD (P830061/S139) | Medtronic Cardiac Rhythm Disease Management | 2016-12-19 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS & XIENCE NANO EECSS (P070015/S135) | Abbott Vascular, Inc. | 2016-12-19 |
| PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM (P960043/S095) | Abbott Vascular, Inc. | 2016-12-19 |
| Attain Bipolar OTW Lead & Attain OTW LV Lead (P010015/S316) | Medtronic, Inc. | 2016-12-19 |
| EVERA MRI ICD/ S DR/ S VR/ XT DR / XTVR ICD; MAXIMO II ICD ; VIVA QUAD XT CRT-D; VIVA S CRT-D; VIVA XT CRT-D (P980016/S614) | Medtronic Cardiac Rhythm Disease Management | 2016-12-19 |
| SELECTSECURE LEAD (P030036/S090) | Medtronic Cardiac Rhythm Disease Management | 2016-12-19 |
| CAPSURE SP NOVUS LEAD / Z LEAD ; CAPSURE Z NOVUS LEAD ; VITATRON IMPLUSE II LEAD (P850089/S122) | Medtronic Cardiac Rhythm Disease Management | 2016-12-19 |
| STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S034) | Abbott Vascular Devices | 2016-12-19 |
| CapSure Epicardial Pacing Lead (P950024/S071) | Medtronic, Inc. | 2016-12-19 |
| HV SPLITTER/ADAPTOR KIT; SPRINT QUATTRO LEAD; SUBCUTANEOUS LEAD ; TRANSVENE CS/SVC LEAD (P920015/S190) | Medtronic, Inc. | 2016-12-19 |
| Protego TD 75/18, 65/18, 65/16; T 65; SD 75/18, 65/18, 65/16, 60/16, S75, S65, S60; Protego DF-1 TD 75/18, 65/18, 65/16; (P980023/S079) | Biotronik, Inc. | 2016-12-19 |
| CAPSUREFIX LEAD; CAPSUREFIX NOVUS LEAD; VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S164) | Medtronic, Inc. | 2016-12-19 |
| ATTAIN STARFIX LEAD (P060039/S076) | Medtronic, Inc. | 2016-12-19 |
| ATTAIN ABILITY LEAD & ATTAIN PERFORMA LEAD (P080006/S104) | Medtronic, Inc. | 2016-12-19 |
| ELLIPSE (P910023/S377) | ABBOTT MEDICAL | 2016-12-19 |
| SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) (P110042/S071) | Boston Scientific Corporation | 2016-12-19 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S156) | Boston Scientific Corp | 2016-12-19 |
| XIENCE PRIME /XIENCE XPEDITION /ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S088) | Abbott Vascular | 2016-12-19 |
| Linox smart TD 75/18/ 65/18/ 65/16; Linox smart SD 75/18/ 65/18/ 65/16 60/16; Linox smart T65/ S75/ D65/S60; Linox smart (P950037/S170) | Biotronik, Inc. | 2016-12-19 |
| ACUITY X4 Lead Models 4671, 4672, 4674, 4675, 4677, 4678 (P010012/S440) | Boston Scientific Corp | 2016-12-19 |
| INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM (P140028/S022) | Boston Scientific Corporation | 2016-12-19 |
| MEDTRONIC COREVALVE SYSTEM (P130021/S027) | Medtronic, Inc. | 2016-12-18 |
| GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S036) | W. L. Gore & Associates, Inc. | 2016-12-16 |
| PMA NIT-OCCLUD PDA (P120009/S003) | Pfm Medical, Inc. | 2016-12-16 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S027) | Boston Scientific Corporation | 2016-12-16 |
| VIABAHN ENDOPROSTHESIS (P040037/S097) | W. L. Gore & Associates, Inc. | 2016-12-16 |
| Reply/Esprit Pacemakers Sorin CRM. (P950029/S113) | MicroPort CRM USA, Inc. | 2016-12-16 |
| ZILVER VASCULAR STENT (P050017/S014) | Cook Ireland, Ltd. | 2016-12-16 |
| LUTONIX DRUG COATED BALLOON (P130024/S017) | Lutonix | 2016-12-16 |
| VISIONIST, VISIONIST X4, VALITUDE, VALITUDE X4, INVIVE, INTUA (P030005/S138) | Guidant Corp. | 2016-12-16 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S090) | W. L. Gore & Associates, Inc. | 2016-12-16 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S021) | Cook Ireland, Ltd. | 2016-12-16 |
| GORE CARDIOFORM SEPTAL OCCLUDER SHARED HLC IN-LINE DIPPER (P050006/S055) | W. L. Gore & Associates, Inc. | 2016-12-15 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S096) | W. L. Gore & Associates, Inc. | 2016-12-15 |
| GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S035) | W. L. Gore & Associates, Inc. | 2016-12-15 |
| MECHANICAL HEART VALVES (P810002/S099) | ABBOTT MEDICAL | 2016-12-15 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S089) | W. L. Gore & Associates, Inc. | 2016-12-15 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S139) | W. L. Gore & Associates, Inc. | 2016-12-15 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S087) | Medtronic | 2016-12-15 |
| CapSure Epicardial Pacing Lead (P950024/S070) | Medtronic, Inc. | 2016-12-14 |
| GORE TIGRIS VASCULAR STENT (P160004/S002) | W. L. Gore & Associates, Inc. | 2016-12-14 |
| REVO MRI SURESCAN IPG AND CAPSUREFIX MRI LEAD (P090013/S241) | Medtronic, Inc. | 2016-12-14 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S571) | Medtronic Cardiac Rhythm Disease Management | 2016-12-14 |
| ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD, CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S313) | Medtronic, Inc. | 2016-12-14 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S611) | Medtronic Cardiac Rhythm Disease Management | 2016-12-14 |
| ATTAIN STARFIX MODEL 4195 LEAD (P060039/S075) | Medtronic, Inc. | 2016-12-14 |
| Adapta, Versa, Sensia IPG Models ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, S (P980035/S484) | Medtronic, Inc. | 2016-12-14 |
| MEDTRONIC ATTAIN ABILITY/PERFORMA LEAD (P080006/S103) | Medtronic, Inc. | 2016-12-14 |
| MEDTRONIC(R) CAPSUREFIX LEAD (P930039/S163) | Medtronic, Inc. | 2016-12-14 |
| MEDTRONIC SELECTSECURE LEAD/ANCHORING SLEEVE KIT (P030036/S089) | Medtronic Cardiac Rhythm Disease Management | 2016-12-14 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S062) | ABBOTT MEDICAL | 2016-12-14 |
| ADHESIVE, CAPSURE SENSE LEAD, CAPSURE SP LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE AND EXCELLENCE PS+ LEAD (P830061/S138) | Medtronic Cardiac Rhythm Disease Management | 2016-12-14 |
| MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM (P900061/S144) | Medtronic Cardiac Rhythm Disease Management | 2016-12-14 |
| IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S027) | Medtronic, Inc. | 2016-12-14 |
| MEDTRONIC.KAPPA 400 SERIES PACEMAKERS (P970012/S100) | Medtronic, Inc. | 2016-12-14 |
| DISPOSABLE EPG COVER/DISPOSABLE POUCH (P820003/S137) | Medtronic Cardiac Rhythm Disease Management | 2016-12-14 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S062) | Boston Scientific Corp | 2016-12-14 |
| ATRICURE SYNERGY ABLATION SYSTEM (P100046/S007) | AtriCure, Inc. | 2016-12-14 |
| CAPSURE SP NOVUS, CAPSURE SP Z, CAPSURE Z NOVUS, VITATRON IMPULSE II LEAD (P850089/S121) | Medtronic Cardiac Rhythm Disease Management | 2016-12-14 |
| Analyzer Software,Battery Check Monitor,CapSure VDD 2 Lead,CareLink Programmer,CareLink Programmer RF (P890003/S367) | Medtronic, Inc. | 2016-12-14 |
| MYOCARDIAL PACING LEAD (P120017/S007) | Medtronic, Inc. | 2016-12-14 |
| Catheter RF Contactr, Catheter RF Enhancr II (P930029/S057) | Medtronic, Inc. | 2016-12-14 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S027) | Edwards Lifesciences, LLC | 2016-12-14 |
| ADAPTA, VERSA, SENSIA IPG (P980035/S482) | Medtronic, Inc. | 2016-12-14 |
| MICRA TPS (P150033/S011) | Medtronic, Inc. | 2016-12-14 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S023) | Medtronic Vascular, Inc. | 2016-12-14 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S026) | Boston Scientific Corp | 2016-12-14 |
| Transvene CS/SVC Lead (P980050/S108) | Medtronic, Inc. | 2016-12-14 |
| WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE (P130013/S011) | Boston Scientific Corp | 2016-12-14 |
| MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015/S189) | Medtronic, Inc. | 2016-12-14 |
| Qualcrimp crimping accessory (Packaged with the Commander Delivery System) (P140031/S026) | Edwards Lifesciences, LLC | 2016-12-13 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S142) | Edwards Lifesciences, LLC | 2016-12-13 |
| INTELLANAV MIFI XP; INTELLATIP MIFI XP (P020025/S091) | Boston Scientific | 2016-12-13 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S088) | Medtronic | 2016-12-13 |
| Qualcrimp crimping accessory (Packaged with the NovaFlex+ Delivery System) (P130009/S067) | Edwards Lifesciences, LLC | 2016-12-13 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S077) | Medtronic | 2016-12-13 |
| WOLVERINE CORONARY CUTTING BALLOON (P950020/S078) | Boston Scientific Corp | 2016-12-12 |
| AUTOGEN X4 CRT-D MODEL G166, G168 and AUTOGEN CRT-D MODELS G160, G161, G164 (P010012/S424) | Boston Scientific Corp | 2016-12-12 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM. (P130030/S033) | Boston Scientific Corp | 2016-12-12 |
| ESSENTIO MRI Models L110, L111, L131; (P150012/S020) | Boston Scientific | 2016-12-12 |