| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S045) | W. L. Gore & Associates, Inc. | 2017-11-16 |
| Preference (tetrafilcon A) Soft (hydrophillic) Contact Lenses (N17679/S038) | CooperVision, Inc. | 2017-11-16 |
| Mosaic Bioprosthesis (P990064/S073) | Medtronic, Inc. | 2017-11-16 |
| Juvederm Voluma XC, Juvederm Vollure XC, Juvederm Volbella XC (P110033/S034) | Allergan | 2017-11-16 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S001) | Medtronic Vascular | 2017-11-16 |
| Avalus (P170006/S003) | Medtronic, Inc. | 2017-11-16 |
| Freestyle Bioprosthesis (P970031/S061) | Medtronic, Inc. | 2017-11-16 |
| CoreValve, Evolut-R Evolut PRO (P130021/S045) | Medtronic, Inc. | 2017-11-16 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S053) | Zimmer, Inc. | 2017-11-15 |
| Artus CMV RGQ and QS-RGQ MDx Kit (P130027/S003) | Qiagen, Inc. | 2017-11-15 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S086) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-11-15 |
| ProDisc-L Total Disc Replacement (P050010/S019) | Centinel Spine, LLC | 2017-11-15 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S096) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2017-11-15 |
| Wolverine Coronary Cutting Balloon (Monorail; Over-theWire) (P950020/S086) | Boston Scientific Corp | 2017-11-15 |
| Dimension Vista FPSA Flex reagent cartridge (P020027/S029) | Siemens Healthcare Diagnostics | 2017-11-14 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S280) | Boston Scientific Corp | 2017-11-14 |
| LifeStent Vascular Stent System (P070014/S053) | Bard Peripheral Vascular, Inc. | 2017-11-14 |
| Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S068) | Dexcom, Inc. | 2017-11-14 |
| Dimension Vista TPSA Flex reagent cartridge (P000021/S034) | Siemens Healthcare Diagnostics | 2017-11-14 |
| HiFocus SlimJ Electrode (P960058/S121) | Advanced Bionics | 2017-11-14 |
| HiResolution Bionic Ear System (P960058/S122) | Advanced Bionics | 2017-11-14 |
| Consulta CRT-P, Percepta Bipolar CRT-P / Percepta Quadripolar CRT-P, Serena Bipolar CRT-P / Serena Quadripolar CRT-P, So (P010015/S345) | Medtronic, Inc. | 2017-11-13 |
| Edwards Commander Delivery System (P140031/S056) | Edwards Lifesciences, LLC | 2017-11-13 |
| Cobas 4800 BRAF V600 Mutation Test (P110020/S023) | Roche Molecular Systems, Inc. | 2017-11-13 |
| Cobas HCV (P150015/S010) | Roche Molecular Systems, Inc. | 2017-11-13 |
| Cobas HPV Test (P100020/S027) | Roche Molecular Systems, Inc. | 2017-11-13 |
| Cobas HBV (P150014/S011) | Roche Molecular Systems, Inc. | 2017-11-13 |
| TRIVISC (P160057) | Channel-Markers Medical, LLC | 2017-11-13 |
| Roche Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0 (P050028/S059) | Roche Molecular Systems, Inc. | 2017-11-13 |
| Cobas EGFR Mutation Test and Cobas EGFR v2 Mutation Test (P120019/S017) | Roche | 2017-11-13 |
| Cobas CMV (P160041/S003) | Roche Molecular Systems, Inc. | 2017-11-13 |
| Revo MRI SureScan IPG (P090013/S264) | Medtronic, Inc. | 2017-11-13 |
| Advisa DR IPG / DR MRI IPG/ SR MRI IPG; Astra XT DR MRI IPG / S DR MRI IPG / S SR MRI IPG/ XT SR MRI IPG; AZURA S DR MRI (P980035/S523) | Medtronic, Inc. | 2017-11-13 |
| AIR OPTIX plus HydraGlyde (lotrafilcon B) Soft Contact Lenses for Daily and Extedned Wear (P010019/S061) | Alcon Laboratories, Inc. | 2017-11-13 |
| Biofinity Toric (P080011/S062) | CooperVision, Inc. | 2017-11-13 |
| Cobas KRAS Mutation Test (P140023/S012) | Roche Molecular Systems, Inc. | 2017-11-13 |
| Assurity MRI and Endurity MRI family of Pacemakers, (P140033/S017) | ABBOTT MEDICAL | 2017-11-09 |
| Microny family of Pacemakers (P970013/S075) | ABBOTT MEDICAL | 2017-11-09 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S049) | Baxter Healthcare Corp | 2017-11-09 |
| Epic Vascular Self-Expanding Stent System (P110035/S042) | Boston Scientific Corp | 2017-11-09 |
| InterStim Therapy System, Verify Evaluation System (Bowel) (P080025/S154) | Medtronic Neuromodulation | 2017-11-09 |
| Medtronic Attain Ability Model 4196 (P080006/S114) | Medtronic, Inc. | 2017-11-09 |
| CapSure Epicardial Pacing Lead (P950024/S076) | Medtronic, Inc. | 2017-11-09 |
| Innova Self-Expanding Stent System (P140028/S029) | Boston Scientific Corporation | 2017-11-09 |
| InterStim Therapy System, Verify Evaluation System (Urinary) (P970004/S259) | Medtronic Neuromodulation | 2017-11-09 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S177) | Medtronic, Inc. | 2017-11-09 |
| Anthem, Allure/RF,Allura Quadra/RF family of CRT-Ps (P030035/S162) | ABBOTT MEDICAL | 2017-11-09 |
| Epic Vascular Self-Expanding Stent System (P110035/S043) | Boston Scientific Corp | 2017-11-09 |
| CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead (P830061/S151) | Medtronic Cardiac Rhythm Disease Management | 2017-11-09 |
| Promote/+/RF/Q. Promote Accel, Promote Quadra, Unity, Unity Assura, Unity Quadra, Quadra Assura , Epic+/HF/HF+/ II HF, A (P030054/S340) | ABBOTT MEDICAL | 2017-11-09 |
| CapSure VDD 2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S382) | Medtronic, Inc. | 2017-11-09 |
| Cartiva Synthetic Cartilage Implant (P150017/S006) | Cartiva, Inc. | 2017-11-09 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S290) | ABBOTT MEDICAL | 2017-11-09 |
| CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S128) | Medtronic Cardiac Rhythm Disease Management | 2017-11-09 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify, Assura, Epic/Epic+, Atlas/II/+ familyof ICD's (P910023/S396) | ABBOTT MEDICAL | 2017-11-09 |
| Vitros Immunodiagnostic Products HBs Ag Reagent Pack and Calibrator (P000044/S036) | Ortho-Clinical Diagnostics, Inc. | 2017-11-09 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Ellipse (P030054/S339) | ABBOTT MEDICAL | 2017-11-08 |
| Assurity MRI, Endurity MRI (P140033/S016) | ABBOTT MEDICAL | 2017-11-08 |
| Siello S and Solia S, EFH-6F-W and DH IS-1/DF4 (P950037/S181) | Biotronik, Inc. | 2017-11-08 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S087) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-11-08 |
| CERAMAX® Ceramic Total Hip System (P070026/S046) | DePuy Orthopaedics, Inc. | 2017-11-08 |
| Accent, Assurity, Endurity, Verity ADx, Zephyr, Identity ADx, Victory (P880086/S289) | ABBOTT MEDICAL | 2017-11-08 |
| Anthem, Allure/Allure RF, Allure Quadra / Allure Quadra RF, Allure Quadra MP RF (P030035/S161) | ABBOTT MEDICAL | 2017-11-08 |
| Microny (P970013/S074) | ABBOTT MEDICAL | 2017-11-08 |
| Fortify, Fortify Assura, Quadra Assura, Ellipse (P910023/S395) | ABBOTT MEDICAL | 2017-11-08 |
| Inspire IV IPG (P130008/S027) | Inspire Medical Systems | 2017-11-08 |
| Floseal Hemostatic Matrix (P990009/S048) | Baxter Healthcare Corp | 2017-11-08 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S084) | Medtronic Vascular | 2017-11-07 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S010) | Medtronic Vascular | 2017-11-07 |
| Resolute Onyx Coronary Stent System (P160043/S009) | Medtronic Vascular | 2017-11-07 |
| Resolute Integrity Coronary Stent System (P110013/S083) | Medtronic Vascular | 2017-11-07 |
| MiniMed 670G System with SmartGuard (P160017/S024) | Medtronic Minimed, Inc. | 2017-11-07 |
| Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System (P940016/S024) | B. Braun Avitum AG | 2017-11-07 |
| MiniMed 630G System with SmartGuard (P150001/S026) | Medtronic Minimed | 2017-11-07 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S005) | Biotronik AG | 2017-11-06 |
| LCS Total Knee System (P830055/S188) | Depuy, Inc. | 2017-11-06 |
| Cologuard (P130017/S017) | Exact Sciences Corporation | 2017-11-06 |
| VENTANA ALK (D5F3) CDx Assay (P140025/S006) | Ventana Medical Systems, Inc. | 2017-11-06 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S085) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-11-06 |
| Astron Pulsar/Pulsar - 18 Stent System (P160025/S003) | Biotronik AG | 2017-11-06 |
| Activa Deep Brain Stimulation Therapy System (P960009/S299) | Medtronic, Inc. | 2017-11-03 |
| Dexcom G4 PLATINUM Continuous Glucose Monitoring System; Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S060) | Dexcom, Inc. | 2017-11-03 |
| Restore, and Itrel Spinal Cord Stimulation Systems (P840001/S380) | Medtronic Neuromodulation | 2017-11-03 |
| Progensa PCA3 Assay (P100033/S007) | Gen-Probe Incorporated | 2017-11-03 |
| Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046/S026) | Allergan | 2017-11-03 |
| Aptima HPV Assay (P100042/S014) | Gen-Probe Incorporated | 2017-11-03 |
| Aptima HCV RNA Qualitative Assay (P020011/S010) | Gen-Probe | 2017-11-03 |
| Natrelle Silicone-Filled Breast Implants (P020056/S045) | Allergan | 2017-11-03 |
| InterStim Therapy System (P080025/S153) | Medtronic Neuromodulation | 2017-11-03 |
| Natrelle Saline-Filled Breast Implants (P990074/S041) | Allergan | 2017-11-03 |
| Elecsys Anti-HCV II, PreciControl Anti-HCV (P140021/S010) | Roche Diagnostics Operations, Inc. | 2017-11-03 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S012) | Gen-Probe Incorporated | 2017-11-03 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S081) | Boston Scientific Corp | 2017-11-03 |
| InterStim Therapy System (P970004/S258) | Medtronic Neuromodulation | 2017-11-03 |
| Rotablator Rotational Atherectomy System (P900056/S165) | Boston Scientific Corp | 2017-11-02 |
| Cool Point Tubing Set (P060019/S041) | Irvine Biomedical, Inc. | 2017-11-02 |
| Provisc Ophthalmic Viscosurgical Devices (P890047/S052) | Alcon Research, Ltd. | 2017-11-01 |
| Blazer II XP Cardiac RF Ablation System(also branded as as Blazer (II XP, PRime XP); IntellaTip MiFi XP; IntellaNav XP a (P020025/S108) | Boston Scientific | 2017-11-01 |
| Chilli II Cooled RF Ablation System (P980003/S082) | Boston Scientific Corp | 2017-11-01 |
| Duovisc, Viscoat, Discovisc Ophthalmic Viscosurgical Devices (P840064/S067) | Alcon Laboratories | 2017-11-01 |