| PSW 1704.U (P000009/S075) | Biotronik, Inc. | 2017-12-12 |
| AMS 700 Implantable Penile Prosthesis with and without InhibiZone (N970012/S142) | Boston Scientific Corp | 2017-12-12 |
| Cobas HCV (P150015/S011) | Roche Molecular Systems, Inc. | 2017-12-11 |
| Unify/ Unify Quadra/ Unify Assura/ Quadra Assura/ Quadra Assura MP (P030054/S342) | ABBOTT MEDICAL | 2017-12-11 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Protecta ICD, Prote (P980016/S647) | Medtronic Cardiac Rhythm Disease Management | 2017-12-11 |
| Accolade Non-MRI Pacemakers: ALTRUA 2, ESSENTIO, PROPONENT and ACCOLADE (N970003/S219) | Boston Scientific Corp | 2017-12-11 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S608) | Medtronic Cardiac Rhythm Disease Management | 2017-12-11 |
| NG3 Implantable Cardiac Defibrillators (ICDs): AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 ICDs: MOMENTUM, VIGILANT, PERCIV (P960040/S410) | Boston Scientific | 2017-12-11 |
| NG3 Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Devices: AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 CRT-D Devi (P010012/S469) | Boston Scientific Corp | 2017-12-11 |
| Cobas CMV (P160041/S004) | Roche Molecular Systems, Inc. | 2017-12-11 |
| Revo MRI SureScan IPG (P090013/S266) | Medtronic, Inc. | 2017-12-11 |
| Fortify; Fortify Assura (P910023/S398) | ABBOTT MEDICAL | 2017-12-11 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra XT DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra (P980035/S526) | Medtronic, Inc. | 2017-12-11 |
| Consulta CRT-P, Percepta Bipolar CRT-P,Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solar (P010015/S347) | Medtronic, Inc. | 2017-12-11 |
| CoreValve Evolut R System and CoreValve Evolut Pro System (P130021/S047) | Medtronic, Inc. | 2017-12-11 |
| Accolade Cardiac Resynchronization Therapy-Pacemaker (CRT-P) Devices: VALITUDE, VALITUDE, and VISIONIST (P030005/S167) | Guidant Corp. | 2017-12-11 |
| Accolade MRI Pacemakers: ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI (P150012/S046) | Boston Scientific | 2017-12-11 |
| Final Crimp Stopper (P140031/S058) | Edwards Lifesciences, LLC | 2017-12-11 |
| Sapien 3 Transcatheter Heart Valve (P140031/S057) | Edwards Lifesciences, LLC | 2017-12-11 |
| Cobas HBV (P150014/S012) | Roche Molecular Systems, Inc. | 2017-12-11 |
| Infinity family of DBS IPGs (P140009/S030) | ABBOTT MEDICAL | 2017-12-09 |
| EonC and Eon Mini Neurostimulation System (P010032/S135) | ABBOTT MEDICAL | 2017-12-09 |
| NeuroPace RNS System (P100026/S050) | NeuroPace, Inc. | 2017-12-09 |
| Proclaim Elite family of SCS IPGs (P010032/S134) | ABBOTT MEDICAL | 2017-12-09 |
| Proclaim DRG family of DRG IPGs (P150004/S014) | ABBOTT MEDICAL | 2017-12-09 |
| Axium Clinical and Patient Programmers (P150004/S016) | ABBOTT MEDICAL | 2017-12-08 |
| EDWARDS INTUITY ELITE Valve System (P150036/S021) | Edwards Lifesciences, LLC | 2017-12-08 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S171) | Edwards Lifesciences, LLC | 2017-12-08 |
| Freestyle Libre Flash Glucose Monitoring System (P160030/S001) | Abbott Diabetes Care, Inc. | 2017-12-08 |
| Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve (P150048/S010) | Edwards Lifesciences, LLC | 2017-12-08 |
| VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM (P150031) | Boston Scientific Corp | 2017-12-08 |
| Inspire IV IPG (P130008/S028) | Inspire Medical Systems | 2017-12-08 |
| RelayPlus Thoracic Stent-Graft System (P110038/S016) | Bolton Medical, Inc. | 2017-12-08 |
| SynCardia temporary Total Artificial Heart (TAH-t) System / Companion 2 Driver System (P030011/S057) | Syncardia Systems, LLC | 2017-12-08 |
| MiniMed 670G System (P160017/S020) | Medtronic Minimed, Inc. | 2017-12-08 |
| Fortify Assura , Ellipse (P910023/S397) | ABBOTT MEDICAL | 2017-12-07 |
| Unify/ Unify Quadra/ Unify Assura / Quadra Assura MP (P030054/S341) | ABBOTT MEDICAL | 2017-12-07 |
| Rayner C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular Lenses (P060011/S013) | Rayner Intraocular Lenses , Ltd. | 2017-12-07 |
| Tendril MRI (P140033/S020) | ABBOTT MEDICAL | 2017-12-07 |
| QuantiFERON-TB Gold and QuantiFERON -TB Gold Plus. (P010033/S036) | Qiagen | 2017-12-07 |
| Tendril ST; Tendril STS; Optisense (P960013/S093) | ABBOTT MEDICAL | 2017-12-07 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S059) | Syncardia Systems, LLC | 2017-12-07 |
| ALTRUA 2, ESSONTIO, PROPONENT, ACCOLADE, ADVANTIO, INGENIO, VITALIO, Non-MRI Pacemakers (N970003/S220) | Boston Scientific Corp | 2017-12-06 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI, MRI Pacemakers (P150012/S048) | Boston Scientific | 2017-12-06 |
| ESSENTIO MRI / PROPONENT MRI /ACCOLADE MRI / Accolade MRI Pacemakers (P150012/S049) | Boston Scientific | 2017-12-06 |
| Master Restore, Itrel and Intellis Spinal Cord Stimulation Systems adn Pisces, Specify, and Vectris Spinal COrd Stimulat (P840001/S382) | Medtronic Neuromodulation | 2017-12-06 |
| ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, RESONATE, PERCIVA, PUNCTUA, ENERGEN, INCEPTA , Inplantable Cardiov (P960040/S411) | Boston Scientific | 2017-12-06 |
| Oncomine Dx Target Test (P160045/S002) | Life Technologies Corporation | 2017-12-06 |
| Vysis CLL Fish Probe Kit (P150041/S001) | Abbott Molecular, Inc. | 2017-12-06 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S089) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-12-06 |
| ORIGEN / INOGEN / DYNAGEN / AUTOGEN / MOMENTUM / VIGILANT / RESONATE / Implantable Cardiac Resynchronization Therapy Def (P010012/S471) | Boston Scientific Corp | 2017-12-06 |
| SynCardia temporary Total Artificial Heart (TAH-T) System (P030011/S050) | Syncardia Systems, LLC | 2017-12-06 |
| VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4, INVIVE, INTUA Cardiac Resynchronization Therapy-Pacemaler (CRT-P) (P030005/S168) | Guidant Corp. | 2017-12-06 |
| ALTRUA 2 / ESSENTIO / PROPONENT / ACCOLADE / Accolade Non-MRI Pacemakers (N970003/S221) | Boston Scientific Corp | 2017-12-06 |
| Path Vysion HER-2 DNA Probe Kit (P980024/S016) | Abbott Molecular, Inc. | 2017-12-06 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S007) | Medtronic Vascular | 2017-12-06 |
| EMBLEM SICD GEN 2, SICD EMBLEM MRI , Subcutaneous Implantable Cardioverter Defibrillator (SICD) (P110042/S097) | Boston Scientific Corporation | 2017-12-06 |
| Mentor-Saline-Filled and Spectrum Breast Implants (P990075/S043) | Mentor Worldwide, LLC | 2017-12-06 |
| ORIGEN / INOGEN / DYNAGEN /AUTOGEN /MOMENTUM /VIGILANT/ PERCIVA / RESONATE/ Implantable Cardioverter Defibrillator (ICD) (P960040/S413) | Boston Scientific | 2017-12-06 |
| ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, RESONATE, PERCIVA, PUNCTUA, ENERGEN, INCEPTA , Cardiac Resynchroni (P010012/S470) | Boston Scientific Corp | 2017-12-06 |
| VALITUDE / VALITUDE X4 / VISIONIST / VISIONIST X4 / Accolade C ardiac Resynchronization Therapy-Pacemaker (CRT-P) Device (P030005/S169) | Guidant Corp. | 2017-12-06 |
| Mentor MemoryShape Breast Implants (P060028/S027) | Mentor Worldwide, LLC | 2017-12-06 |
| Activa Deep Brain Stimulation Therapy System (P960009/S301) | Medtronic, Inc. | 2017-12-06 |
| Vysis ALK Break Apart Fish Probe Kit (P110012/S014) | Abbott Molecular, Inc. | 2017-12-06 |
| Mentor MemoryGel Breast Implants (P030053/S044) | Mentor Corp. | 2017-12-06 |
| UroVysion Bladder Cancer Kit (P030052/S021) | Abbott Molecular | 2017-12-06 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S346) | Medtronic, Inc. | 2017-12-05 |
| Revo MRI SureScan IPG (P090013/S265) | Medtronic, Inc. | 2017-12-05 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Pro (P980016/S646) | Medtronic Cardiac Rhythm Disease Management | 2017-12-05 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S016) | Boston Scientific Corp | 2017-12-05 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra XT DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra (P980035/S525) | Medtronic, Inc. | 2017-12-05 |
| ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA (P000037/S050) | On-X Life Technologies, Inc. | 2017-12-05 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S607) | Medtronic Cardiac Rhythm Disease Management | 2017-12-05 |
| SYNCHROMED II PUMP REMEDIATION (P860004/S268) | Medtronic, Inc. | 2017-12-05 |
| EnVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL), Model MX60E Lens Holder (P910056/S028) | Bausch & Lomb, Inc. | 2017-12-04 |
| Essure System for Permanent Birth Control (P020014/S049) | Bayer Pharma AG | 2017-12-04 |
| Adapta, Versa, Sensia IPG/Attesta IPG/Relia IPG/Sphera IPG (P980035/S527) | Medtronic, Inc. | 2017-12-04 |
| Rotablator Rotational Atherectomy System (P900056/S168) | Boston Scientific Corp | 2017-12-01 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S088) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-12-01 |
| Evera MRI DF-I ICD,EVERA MRI ICD, Evera S DR/S VR/XT DR/ XT VR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maxmo II ICD, (P980016/S640) | Medtronic Cardiac Rhythm Disease Management | 2017-12-01 |
| Revo MRI SureScan IPG (P090013/S263) | Medtronic, Inc. | 2017-12-01 |
| Emblem S-ICD System Model A209 / Emblem MRI S-ICD System Model A219 (P110042/S096) | Boston Scientific Corporation | 2017-12-01 |
| Adapta, Versa, Sensia IPG, Adapta, Versa Sensia IPG, Advisa DR IPG, Advisa DR /SR MRI IPG, Astra S DR/S SR XTDR/ XT SR M (P980035/S519) | Medtronic, Inc. | 2017-12-01 |
| Accolade MRI, Essentio MRI, Proponent MRI (Accolade MRI) (P150012/S045) | Boston Scientific | 2017-12-01 |
| Express SD Monorail Premounted Stent System (P060006/S088) | Boston Scientific Corp | 2017-12-01 |
| Consulta CRT-P, Percepta Biploar CRT-P. Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P; Sola (P010015/S343) | Medtronic, Inc. | 2017-12-01 |
| Accolade, Altrua 2, Essentio, Proponent (Accolade), Advantio, Ingenio, Vitalio, Formio (Ingenio) (N970003/S218) | Boston Scientific Corp | 2017-12-01 |
| CareLink Express Monitor, Monitor CardioSight Reader, My CareLink Patient Monitor. (P890003/S381) | Medtronic, Inc. | 2017-12-01 |
| Micra TPS (P150033/S027) | Medtronic, Inc. | 2017-12-01 |
| Sientra OPUS Silicone Gel Breast Implants (P070004/S010) | Tiger Aesthetics Medical, LLC | 2017-12-01 |
| SynCardia temporary Total Artificial Heart (TAH-t) System; Freedom Driver System (P030011/S058) | Syncardia Systems, LLC | 2017-12-01 |
| Amplia MRI CRT-D/ Amplia MRI Quad CRT-D; Brava CRT-D/ Brava Quad CRT-D; Claria MRI CRT-D. Claria MRI CRT-D; Compia MRI C (P010031/S601) | Medtronic Cardiac Rhythm Disease Management | 2017-12-01 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S109) | Boston Scientific | 2017-12-01 |
| PROMUS Elemen Plus Everolimus-Eiuting Stent System/ PROMUS PREMIER Everolimus-Eiuting Platinum Chromium Coronary Stent S (P110010/S149) | Boston Scientific Corp | 2017-12-01 |
| Plasma Treatment System (P910073/S144) | Boston Scientific | 2017-12-01 |
| Autogen, Dynagen, Inogen, Origen (NG3 CRT-Ds), Momentum, Resonate, Vigilant (NG4 CRT-Ds) (P010012/S468) | Boston Scientific Corp | 2017-12-01 |
| Spectra WaveWriter SCS System (P030017/S305) | Boston Scientific Corp | 2017-12-01 |
| Valitude, Valitude X4, Visionist, Visionist X4 (Accolade (CRT-Ps), Intua, Invive (Ingenio CRT-Ps) (P030005/S166) | Guidant Corp. | 2017-12-01 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S046) | Boston Scientific Corp | 2017-12-01 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S032) | Boston Scientific Corp | 2017-12-01 |