| ADVANTIO, INGENIO, VITALO, FORMIO, ESSENTO, ACCOLADE, PROPONENT Families of Pacemaker Devices (N970003/S207) | Boston Scientific Corp | 2017-08-07 |
| CRT-P Resynchronization Devices INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S155) | Guidant Corp. | 2017-08-07 |
| Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System. (P150023/S007) | Abbott Vascular, Inc. | 2017-08-07 |
| NIRXCELL COCR CORONARYSTENT ON RX SYSTEM (P110004/S015) | Medinol, Ltd. | 2017-08-07 |
| Subcutaneous ICD Devices EMBLEM (P110042/S086) | Boston Scientific Corporation | 2017-08-07 |
| CardioGenesis TMR System (P970029/S033) | Cryolife, Inc. | 2017-08-07 |
| HeartWare Ventricular Assist Device System (P100047/S102) | Medtronic | 2017-08-04 |
| SelectSecure MRI SureScan Lead (P030036/S094) | Medtronic Cardiac Rhythm Disease Management | 2017-08-03 |
| CapSureFix Novus MRI SureScan Lead (P930039/S169) | Medtronic, Inc. | 2017-08-03 |
| CapSureFix Novus MRI SureScan Lead (P090013/S254) | Medtronic, Inc. | 2017-08-03 |
| CapSureFix Novus MRI SureScan Lead (4074 and 4574) (P830061/S144) | Medtronic, Inc. | 2017-08-03 |
| AMPLATZER PFO Occluder (P120021/S004) | ABBOTT MEDICAL | 2017-08-03 |
| CARDIOMEMS HF SYSTEM (P100045/S015) | ABBOTT MEDICAL | 2017-08-03 |
| HeartLight Endoscopic Ablation System (P150026/S001) | Cardiofocus, Inc. | 2017-08-03 |
| AMPLATZER Duct Occluder (P020024/S049) | ABBOTT MEDICAL | 2017-08-03 |
| LifeVest Wearable Defibrillator (P010030/S097) | Zoll Manufacturing Corporation | 2017-08-03 |
| Attesta DR MRI SureScan (P980035/S495) | Medtronic, Inc. | 2017-08-03 |
| AMPLATZER Septal Defect Occluder (and Cribriform Occluder) (P000039/S058) | ABBOTT MEDICAL | 2017-08-03 |
| Reply SR, Reply Dr, Esprit SR, Esprit DR (2nd generation , i.e. V2 ) & (5TH generation i.e.V5) (P950029/S114) | MicroPort CRM USA, Inc. | 2017-08-03 |
| AMPLATZER Muscular VSD Occluder (P040040/S031) | ABBOTT MEDICAL | 2017-08-03 |
| Llivia, Inlexa, Intica 7/5, VR-T/ DR-T DF4 (P050023/S109) | Biotronik, Inc. | 2017-08-02 |
| Edora, Evity, Enitra, Enticos 8 HF-T/ QP (P070008/S083) | Biotronik, Inc. | 2017-08-02 |
| DIAMONDBACK 360 Orbital Atherectomy System (P130005/S017) | Cardiovascular Systems, Inc. | 2017-08-02 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S002) | Berlin Heart, Inc. | 2017-08-02 |
| Impella 2.5 and Impella CP Systems (P140003/S022) | Abiomed, Inc. | 2017-08-01 |
| Rebel Platinum Chromium Coronary Stent System (Monorail) and (Over-the-Wire). (P130030/S040) | Boston Scientific Corp | 2017-08-01 |
| Spectranetics Laser Sheath II (SLS II) GlideLight Catheters (P960042/S059) | Spectranetics (Philips) | 2017-07-31 |
| AVALUS(TM) BIOPROSTHESIS (P170006) | Medtronic, Inc. | 2017-07-31 |
| Carpentier-Edwars PERIMOUNT Pericardial Aortic Bioprosthesis/ ThermaFix tissue process; Carpentier-Edwards PERIMOUNT RSR (P860057/S166) | Edwards Lifesciences, LLC | 2017-07-28 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S081) | Edwards Lifesciences, LLC | 2017-07-28 |
| TMR Holmium Laser System (P970029/S035) | Cryolife, Inc. | 2017-07-28 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S001) | Cook Medical Incorporated | 2017-07-28 |
| Edwards INTUITY Elite Valve System (P150036/S015) | Edwards Lifesciences, LLC | 2017-07-28 |
| IN.PACT Admiral Paclitaxel-Coated Balloon Catheter (P140010/S035) | Medtronic, Inc. | 2017-07-28 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S050) | Edwards Lifesciences, LLC | 2017-07-28 |
| EZ Steer Smart Touch; Thermocooll ST Uni (P040036/S059) | Biosense Webster, Inc. | 2017-07-27 |
| WATCHMAN Left Atrial Appendage Closure Device and Delivery System (P130013/S014) | Boston Scientific Corp | 2017-07-27 |
| EZ Steer Navigational 4mm (TC) (P990025/S053) | Biosense Webster, Inc. | 2017-07-27 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR (P110016/S047) | ABBOTT MEDICAL | 2017-07-27 |
| Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software (P140033/S009) | ABBOTT MEDICAL | 2017-07-27 |
| Ascendra+ Delivery System; Balloon Aortic Valvuloplasty Catheter; NovaFlex+ Delivery System; Crimper; Edwards Ballon Cat (P130009/S080) | Edwards Lifesciences, LLC | 2017-07-27 |
| SMARTVIEW hotspot ; Orchestra Plus Link (P060027/S091) | MicroPort CRM USA, Inc. | 2017-07-27 |
| SMARTVIEW hotspot (P950029/S115) | MicroPort CRM USA, Inc. | 2017-07-27 |
| Sentus ProMRI OTW QP S-75, S-85, S-95, L-75, L-95, S-75/49, S-85/49, S-95/49, L-75/49, L-85/49 and Sentus ProMRI OTW QP (P070008/S086) | Biotronik, Inc. | 2017-07-27 |
| INGEVITY MRI models: 7731, 7732, 7735, 7736, 7740, 7741, 7742 (P150012/S031) | Boston Scientific | 2017-07-27 |
| BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S011) | Boston Scientific Corp | 2017-07-27 |
| EZ Steer Navigational 4mm; C3 EZ Steer Thermocool Nav; Ez Steer Thermocool Non-Navigational 4mm (TC); EZ Steer Thermocoo (P030031/S081) | Biosense Webster, Inc. | 2017-07-27 |
| Commander Delivery System; Certitude Delivery System; Certitude Introducer Sheath; Crimper (P140031/S049) | Edwards Lifesciences, LLC | 2017-07-27 |
| EZ Steer Navigational 8mm (DS) ; Celsius FLTR Uni-Dir. (P010068/S054) | Biosense Webster, Inc. | 2017-07-27 |
| SMARTVIEW hotspot; Orchestra Plus Link (P980049/S126) | MicroPort CRM USA, Inc. | 2017-07-27 |
| Therapeutic Catheters (P950005/S065) | Biosense Webster, Inc. | 2017-07-27 |
| EZ Steer Non- Navigational 8mm (DS) ; EZ Steer DS ; EZ Steer Non-Navigational 4mm (TC) & (THR) ; Celsius 4mm Bi-Dir T ; (P950005/S066) | Biosense Webster, Inc. | 2017-07-27 |
| Percepta/ Serena / Solara Bipolar, Quadripolar CRT-P (P010015/S337) | Medtronic, Inc. | 2017-07-26 |
| STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON (P160049) | The Spectranetics Corp. | 2017-07-26 |
| Attain Ability Leads 4196, 4296, 4396 (P080006/S111) | Medtronic, Inc. | 2017-07-26 |
| Current, Fortify, Fortify Assura (P910023/S387) | ABBOTT MEDICAL | 2017-07-26 |
| Perceval Sutureless Heart Valve (P150011/S010) | Corcym S.r.l. | 2017-07-26 |
| Quartet CRT Leads (P950022/S108) | ABBOTT MEDICAL | 2017-07-26 |
| Promote, Unify Quadra, Assura, Quadra Assura (P030054/S331) | ABBOTT MEDICAL | 2017-07-26 |
| Paradym and Paradym RF, Update to Platinium Embedded Software (P980049/S125) | MicroPort CRM USA, Inc. | 2017-07-26 |
| ASTRA S DR/ XT DR /SR MRI IPG (P980035/S512) | Medtronic, Inc. | 2017-07-26 |
| Paradym and Paradym RF, Update to Platinium Embedded Software (P060027/S090) | MicroPort CRM USA, Inc. | 2017-07-26 |
| Attain StarFix Lead 4195 (P060039/S080) | Medtronic, Inc. | 2017-07-26 |
| Durata and Optisure HV leads (P030054/S330) | ABBOTT MEDICAL | 2017-07-26 |
| Autogen, Dynagen, Inogen, Origen NG3 ICDs; Resonate, Vigilant, Perciva NG4 ICDs (P960040/S396) | Boston Scientific | 2017-07-25 |
| Autogen, Dynagen, Inogen, Origen NG3 CRT-Ds; Resonate, Vigilant, NG4 CRT-Ds; Acuity , Slit Suture Sleeve Accessory for A (P010012/S454) | Boston Scientific Corp | 2017-07-25 |
| Express® SD Monorail® Premounted Stent System (P060006/S083) | Boston Scientific Corp | 2017-07-24 |
| Blazer (II, II HTD, Primie HTD) (P920047/S098) | Boston Scientific Corp | 2017-07-24 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S022) | Boston Scientific Corp | 2017-07-24 |
| ACTUITY X4 QUADRIPOLAR CORONARY VENOUS PACE/SENSE LEADS (P010012/S443) | Boston Scientific Corp | 2017-07-24 |
| Chilli II TM Cooled Ablation Catheter and Cable (P980003/S076) | Boston Scientific Corp | 2017-07-24 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S103) | Boston Scientific | 2017-07-24 |
| Blazer (II XP, Prime XP); IntellaTip MiFi XP; IntellaNav XP and IntellaNav MiFi XP (P020025/S101) | Boston Scientific | 2017-07-24 |
| REBEL TM Platinum Chromium Coronary Stent System (P130030/S041) | Boston Scientific Corp | 2017-07-24 |
| Chilli Cooled RF Ablation System (P980003/S074) | Boston Scientific Corp | 2017-07-24 |
| Blazer IITM Cardiac Ablation Catheter and Cable (P920047/S099) | Boston Scientific Corp | 2017-07-24 |
| PROMUS Element Plus Everolimus-Eiuting Stent System I, PROMUS PREMIER Everolimus-Eiuting Platinum Chromium Coronary (P110010/S142) | Boston Scientific Corp | 2017-07-24 |
| Blazer OI, IntellaNav OI, IntellaTip MiFi OI (P150005/S020) | Boston Scientific Corp | 2017-07-24 |
| Rotablator® Rotational Atherectomy System (P900056/S162) | Boston Scientific Corp | 2017-07-24 |
| ProMRI ICD/CRT-D System (P050023/S110) | Biotronik, Inc. | 2017-07-21 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S046) | Edwards Lifesciences, LLC | 2017-07-20 |
| EDWARDS INTUITY ELITE Valve System (P150036/S014) | Edwards Lifesciences, LLC | 2017-07-20 |
| EDWARDS SAPIEN XT Transcatheter Heart Valve (P130009/S079) | Edwards Lifesciences, LLC | 2017-07-20 |
| Carpentier-Edwards PERIMOUNT RSR Theon/Magna/Plus Pericardial Aortic Bioprosthesis with ThermalFix tissue process, (P860057/S165) | Edwards Lifesciences, LLC | 2017-07-20 |
| Resolute Onyx RX and OTW Coronary Stent Systems (P160043/S003) | Medtronic Vascular | 2017-07-19 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S001) | Bard Peripheral Vascular, Inc. | 2017-07-19 |
| Flair Endovascular Stent Graft (P060002/S039) | Bard Peripheral Vascular | 2017-07-19 |
| CapSure SP Novus Lead/ CapSure SP Z Lead/ CapSure Z Novus Lead/ Vitatron Impulse II Lead (P850089/S125) | Medtronic Cardiac Rhythm Disease Management | 2017-07-18 |
| CapSureFix MRI Lead (P090013/S260) | Medtronic, Inc. | 2017-07-18 |
| Amplia MRI/Quad, Brava/Quad CRT-D, Claria MRI/Quad CRT-D, Compia MRI/Quad CRT-D, Consulta CRT-D, Maximo II CRT-D, Vivad (P010031/S598) | Medtronic Cardiac Rhythm Disease Management | 2017-07-18 |
| Attain StarFix Lead (P060039/S079) | Medtronic, Inc. | 2017-07-18 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S045) | Edwards Lifesciences, LLC | 2017-07-18 |
| CapSure VDD 2 Lead/ Vitron Brilliant S+VDD Lead (P890003/S375) | Medtronic, Inc. | 2017-07-18 |
| Micra TPS (P150033/S025) | Medtronic, Inc. | 2017-07-18 |
| ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S005) | Boston Scientific Corporation | 2017-07-18 |
| SLS / GlideLight (P960042/S058) | Spectranetics (Philips) | 2017-07-18 |
| Attain Ability Lead; Attain Performa Lead (P080006/S110) | Medtronic, Inc. | 2017-07-18 |
| Sprint Quattro Lead/ Subcutanious Lead/ Transvene CS.SVC Lead (P920015/S199) | Medtronic, Inc. | 2017-07-18 |
| ELCA (P910001/S094) | Spectranetics Corp. | 2017-07-18 |
| Adapta, Versa, Sensia IPG, Advisa DR,MRI,SR IPG, Astra S DR, S SR, XT DR, XT SR IPG, Relia IPG (P980035/S511) | Medtronic, Inc. | 2017-07-18 |