| Absolute Pro Vascular Self-Expanding Stent System (P110028/S018) | Abbott Vascular, Inc. | 2017-04-07 |
| Carpentier-Edwards PERIMOUNT pericardial Bioprostheses (P860057/S158) | Edwards Lifesciences, LLC | 2017-04-07 |
| Rx Herculink Elite Renal and Biliary Stent System (P110001/S013) | Abbott Vascular | 2017-04-07 |
| EDWARDS INTUITY Elite Valve System (P150036/S006) | Edwards Lifesciences, LLC | 2017-04-07 |
| HeartWare Left Ventricular Assist System (P100047/S082) | Medtronic | 2017-04-06 |
| Zilver Vascular Stent (P050017/S015) | Cook Ireland, Ltd. | 2017-04-06 |
| XIENCE V XIENCE nano Everolimus Eluting Coronary Stent System; XIENCE PRIMME /Xpedition Everolimus Eluting Coronary Sten (P110019/S090) | Abbott Vascular | 2017-04-06 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S023) | Cook Ireland, Ltd. | 2017-04-06 |
| EnVeo R Delivery Catheter System (P130021/S035) | Medtronic, Inc. | 2017-04-05 |
| En Veo R DCS and En Veo R LS (P130021/S032) | Medtronic, Inc. | 2017-04-04 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S052) | Syncardia Systems, LLC | 2017-04-04 |
| Sapien 3 Transcatheter Heart Valve and Accessories (P140031/S033) | Edwards Lifesciences, LLC | 2017-04-03 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S068) | Edwards Lifesciences, LLC | 2017-04-03 |
| Trifecta Valve with Glide (P100029/S025) | ABBOTT MEDICAL | 2017-04-03 |
| Syncardia Temporary Cardio West Total Artificial Heart (TAH-T) (P030011/S049) | Syncardia Systems, LLC | 2017-03-31 |
| IN.PACT Admiral Paclitaxel-Coated Balloon Catheter (P140010/S030) | Medtronic, Inc. | 2017-03-30 |
| Revo MRI SureScan IPG (P090013/S251) | Medtronic, Inc. | 2017-03-30 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex u, Quartet (P030054/S325) | ABBOTT MEDICAL | 2017-03-30 |
| Amplia MRI CRT-D,MRI Quad CRT-D; Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D; Concerto II CRT (P010031/S586) | Medtronic Cardiac Rhythm Disease Management | 2017-03-30 |
| Anthem, Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure MP (P030035/S155) | ABBOTT MEDICAL | 2017-03-30 |
| Current+, Fortify, Fortify Assura, Ellipse, Promote+ (P910023/S383) | ABBOTT MEDICAL | 2017-03-30 |
| Assurity MRI, Endurity MRI, Tendril MRI (P140033/S004) | ABBOTT MEDICAL | 2017-03-30 |
| IsoFlex Optim (P960030/S054) | ABBOTT MEDICAL | 2017-03-30 |
| Evera MRI ICD, Evera S DR/ S VR ICD's; Evera XT DR ICD/ XT VR ICD; Maximo II ICD; Protecta VR/XT ICD; Secura DR ICD, Sec (P980016/S626) | Medtronic Cardiac Rhythm Disease Management | 2017-03-30 |
| Durata, Durata, Optisure (P950022/S104) | ABBOTT MEDICAL | 2017-03-30 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity ADx, Verity ADx (P880086/S281) | ABBOTT MEDICAL | 2017-03-30 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S322) | Medtronic, Inc. | 2017-03-30 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Relia IPG (P980035/S491) | Medtronic, Inc. | 2017-03-30 |
| Tendril SDX Lead, Tendril ST Lead, OptiSence, Tendril STS Lead (P960013/S092) | ABBOTT MEDICAL | 2017-03-30 |
| Kainox VCS; Linox TD 65/18 & 65/16; SD 75/18, 65/18, 65/18, 60/16; T65, S75,S65, S60; S DX 65/17; S DX 65/15; Protego DF (P980023/S080) | Biotronik, Inc. | 2017-03-29 |
| Angio Seal Vascular Closure Device (P930038/S084) | Terumo Medical Corporation | 2017-03-29 |
| ESSENTIO MRI Models: L110, L111, L131; PROPONENT MRI Models: L210, L211, L231; ACCOLADE MRI Models: L310, L311, L331 (P150012/S026) | Boston Scientific | 2017-03-29 |
| VALITUDE Models: U125, U128; VISIONIST Models: U225, U226, U228 (P030005/S151) | Guidant Corp. | 2017-03-29 |
| ESSENTIO Models: L100, L101, L121; PROPONENT Models: L200, L201, L221; ACCOLADE Models: L300, L301, L321; ALTRUA 2 Model (N970003/S203) | Boston Scientific Corp | 2017-03-29 |
| Micra Transcatheter Pacing System (P150033/S019) | Medtronic, Inc. | 2017-03-28 |
| Pro-Kinetic Energy Coronary Stent System (P160003/S001) | Biotronik AG | 2017-03-24 |
| Freestyle Bioprosthesis, Models 995, 995CS and 995MS (P970031/S056) | Medtronic, Inc. | 2017-03-24 |
| Claria MRI Quad CRT-D SureScan, Amplia MRI Quad CRT-D, Implantable Cardioverter Defibrillators with Cardiac Resynchroniz (P010031/S563) | Medtronic Cardiac Rhythm Disease Management | 2017-03-24 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S097) | Boston Scientific | 2017-03-24 |
| Chilli II Cooled Ablation Catheter andCable (P980003/S072) | Boston Scientific Corp | 2017-03-24 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S003) | Biotronik AG | 2017-03-24 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S096) | Boston Scientific Corp | 2017-03-24 |
| REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P130030/S037) | Boston Scientific Corp | 2017-03-24 |
| PROMUS Element Plus Everolimus-Eluting Stent System/Promus PREMIER Everolimus-Eluting Platinum Chronium Coronary Stent S (P110010/S138) | Boston Scientific Corp | 2017-03-24 |
| Hancock II Bioprosthesis, Models T505 and T510 (P980043/S058) | Medtronic, Inc. | 2017-03-24 |
| PSW 1601.U Pacemaker/ICD/CRT non implanted components (P050023/S104) | Biotronik, Inc. | 2017-03-24 |
| Edora 8, Evity 8, Enitra 8, Enticos 8 HF-T QPs,Edora 8, Evity 8, Enitra 8, Enticos 8 HF-Ts and PSW 1601.U Pacemaker/ICD/ (P070008/S076) | Biotronik, Inc. | 2017-03-24 |
| Mosaic Bioprosthesis, Models 305 and 310 (P990064/S067) | Medtronic, Inc. | 2017-03-24 |
| Edora 8 DR & DR-T, Evity 8 DR-T,Enitra 8 DR-T, Enticos 8 DR-T, Edora 8 SR-T and SR, Evity 8 SR-T, Enitra 8 SR-T,Enticos (P950037/S167) | Biotronik, Inc. | 2017-03-24 |
| Blazer Open Irrigated Cardiac Ablation System (P150005/S016) | Boston Scientific Corp | 2017-03-24 |
| ADAPTA, VERSA, SENSIA IPD; RELIA IPG. (P980035/S475) | Medtronic, Inc. | 2017-03-24 |
| Express SD Monorail Premounted Stent System (P060006/S080) | Boston Scientific Corp | 2017-03-24 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S158) | Boston Scientific Corp | 2017-03-24 |
| PSW 1601.U Pacemaker/ICD/CRT non implanted components (P000009/S069) | Biotronik, Inc. | 2017-03-24 |
| PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S137) | Boston Scientific Corp | 2017-03-23 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S013) | Bolton Medical, Inc. | 2017-03-23 |
| ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM (P160025) | Biotronik AG | 2017-03-23 |
| Arctic Front Catheter, Arctic Front Advance Catheter, Arctic Front Advance ST Catheter, Freezor MAX Catheter, Manual ret (P100010/S062) | Medtronic Cryocath, LP | 2017-03-22 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S054) | W. L. Gore & Associates, Inc. | 2017-03-22 |
| Freezor Catheter, Freezor Xtra Catheter, Freezor MAX Surgical Device, Electrical umbilical cable, Coaxial umbilical cabl (P020045/S081) | Medtronic Cryocath, LP | 2017-03-22 |
| MULTI-LINK VISION/MULTI-LINK 8 LL/SV CORONARY STENT SYSTEMS (P020047/S064) | Abbott Vascular | 2017-03-21 |
| ALTRUA 2 Models: S701, S702, S722 (N970003/S202) | Boston Scientific Corp | 2017-03-21 |
| Tendril SDX/ST/STS and optisense leads (LV active) (P960013/S091) | ABBOTT MEDICAL | 2017-03-21 |
| XIENCE XPEDITION & ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S089) | Abbott Vascular | 2017-03-21 |
| Emblem S-ICD Programmer - Plexus SMT Mfg. Line (P110042/S079) | Boston Scientific Corporation | 2017-03-21 |
| QuickFlex u and Quarlet Leads (CRT) (P030054/S324) | ABBOTT MEDICAL | 2017-03-21 |
| MULTI-LINK RX ULTRA CORONARY STENT SYSTEMS (P970020/S082) | Abbott Vascular, Inc. | 2017-03-21 |
| IsoFlex Optim leads (LV Passive) (P960030/S053) | ABBOTT MEDICAL | 2017-03-21 |
| Tendril MRI leads (MRI) (P140033/S003) | ABBOTT MEDICAL | 2017-03-21 |
| Durata and Optisure Leads (HV Active and Passive) (P950022/S103) | ABBOTT MEDICAL | 2017-03-21 |
| Coaxial Umbilical Cable (P020045/S080) | Medtronic Cryocath, LP | 2017-03-20 |
| Platinium CRT-Ds (Cardiac Resynchronization Therapy-Defibrillator) (P060027/S089) | MicroPort CRM USA, Inc. | 2017-03-20 |
| Platinium VR and Platinium DR ICD's (Implantable Cardioverter Defobrillator) (P980049/S124) | MicroPort CRM USA, Inc. | 2017-03-20 |
| Medtronic CoreValve Evolut PRO System (P130021/S029) | Medtronic, Inc. | 2017-03-20 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE (P130005/S014) | Cardiovascular Systems, Inc. | 2017-03-19 |
| WATCHMAN Left Atrial Appendage Closeure Technology (P130013/S012) | Boston Scientific Corp | 2017-03-16 |
| Perceval Sutureless Heart Valve (P150011/S009) | Corcym S.r.l. | 2017-03-16 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S029) | Medtronic, Inc. | 2017-03-16 |
| Express SD Renal Monorail Premounted Stent System (P060006/S079) | Boston Scientific Corp | 2017-03-15 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S036) | Boston Scientific Corp | 2017-03-15 |
| QUARTET 1457Q LV LEAD (P030054/S314) | ABBOTT MEDICAL | 2017-03-15 |
| IsoFlex Optim leads (LV Passive) (P960030/S051) | ABBOTT MEDICAL | 2017-03-14 |
| QuickFlex µ and Quartet leads (CRT) (P030054/S322) | ABBOTT MEDICAL | 2017-03-14 |
| Tendril SDX/ST/STS and Optisense leads (LV Active) (P960013/S089) | ABBOTT MEDICAL | 2017-03-14 |
| HeartWare Ventricular Assist System (P100047/S091) | Medtronic | 2017-03-14 |
| Durata and Optisure leads (HV Active and Passive) (P950022/S101) | ABBOTT MEDICAL | 2017-03-14 |
| Amplia MRI, Amplia MRI Quad, Brava, Brava Quad, Claria MRI, Claria Quad, Compia MRI, Compia MRI Quad, Viva Quad S, Viva (P010031/S585) | Medtronic Cardiac Rhythm Disease Management | 2017-03-13 |
| Micra TPS (P150033/S017) | Medtronic, Inc. | 2017-03-13 |
| Evera MRI DF-1, Evera MRI, Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Visia AF MRI DF1, Visia AF MRI VR, Visia AF (P980016/S625) | Medtronic Cardiac Rhythm Disease Management | 2017-03-13 |
| Adapta, Versa, Sensia IPG (P980035/S490) | Medtronic, Inc. | 2017-03-10 |
| Revo MRI SureScan IPG (P090013/S250) | Medtronic, Inc. | 2017-03-10 |
| LIFE VEST WEARABLE DEFIBRILLATOR (P010030/S087) | Zoll Manufacturing Corporation | 2017-03-10 |
| Wearable Cardioverter Defibrillator (WCD) 2000 Life Vest (P010030/S092) | Zoll Manufacturing Corporation | 2017-03-10 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Evera MRI ICD, Maximo II ICD (P010031/S582) | Medtronic Cardiac Rhythm Disease Management | 2017-03-10 |
| Evera MRI DF-1, Protecta XT ICD (P980016/S623) | Medtronic Cardiac Rhythm Disease Management | 2017-03-10 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S321) | Medtronic, Inc. | 2017-03-10 |
| Hancock II Bioprosthesis, Ultra Bioprosthesis (P980043/S057) | Medtronic, Inc. | 2017-03-09 |
| Mosaic Bioprosthesis, Mosaic Ultra Bioprosthesis (P990064/S066) | Medtronic, Inc. | 2017-03-09 |
| Medtronic CoreValve System/Medtronic Evolut R System (P130021/S030) | Medtronic, Inc. | 2017-03-09 |
| SynCardia Temporary Total Artificial Heart (P030011/S047) | Syncardia Systems, LLC | 2017-03-09 |