| Vercise Deep Brain Stimulation (DBS) System, Vercise PC Deep Brain Stimulation (DBS) System, and Vercise Gevia Deep Brai (P150031/S030) | Boston Scientific Corp | 2020-04-24 |
| Pathway Clinical Trial Cohort (P150024/S016) | Aspire Bariatrics, Inc. | 2020-04-24 |
| Precision Spinal Cord Stimulator (SCS) System, Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Novi⢠(P030017/S335) | Boston Scientific Corp | 2020-04-24 |
| Alto Abdominal Stent Graft System (P120006/S034) | Endologix, LLC | 2020-04-24 |
| Therapy Ablation Catheter (including Bi-Directional Catheter) Therapy 4mm Thermistor Ablation Catheter (P040014/S039) | Irvine Biomedical, Inc. | 2020-04-24 |
| HeartWare HVAD System (P100047/S144) | Medtronic | 2020-04-24 |
| STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING (P830061/S173) | Medtronic Cardiac Rhythm Disease Management | 2020-04-23 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S MRI ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD (P010031/S699) | Medtronic Cardiac Rhythm Disease Management | 2020-04-23 |
| MEDTRONIC SELECTSECURE LEAD MODEL 3830 (P030036/S111) | Medtronic Cardiac Rhythm Disease Management | 2020-04-23 |
| Cobalt XT HF Quad CRT-D MRI SureScan (DTPA2QQ, DTPA2Q1); Cobalt XT HF CRT-D MRI SureScan (DTPA2D4 and DTPA2Dl); Cobalt H (P010031/S674) | Medtronic Cardiac Rhythm Disease Management | 2020-04-23 |
| AcrySof Intraocular Lenses and Delivery System (P930014/S129) | Alcon Laboratories, Inc. | 2020-04-23 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD (P080006/S137) | Medtronic, Inc. | 2020-04-23 |
| Cobalt XT DR MRI SureScan (DDPA2D4 and DDPA2Dl); Cobalt DR MRI SureScan (DDPB3D4 and DDPB3Dl); Crome DR MRI SureScan (DD (P980016/S713) | Medtronic Cardiac Rhythm Disease Management | 2020-04-23 |
| 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 (P980016/S738) | Medtronic Cardiac Rhythm Disease Management | 2020-04-23 |
| IPure Preloaded IOL System (P080004/S028) | Hoya Surgical Optics, Inc. | 2020-04-23 |
| MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568 (P930039/S202) | Medtronic, Inc. | 2020-04-23 |
| MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015/S234) | Medtronic, Inc. | 2020-04-23 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013/S301) | Medtronic, Inc. | 2020-04-23 |
| SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (P890003/S416) | Medtronic, Inc. | 2020-04-23 |
| LCS Total Knee System (P830055/S243) | Depuy, Inc. | 2020-04-22 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S434) | Medtronic, Inc. | 2020-04-22 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D, Compia MRI Quad CRT- (P010031/S698) | Medtronic Cardiac Rhythm Disease Management | 2020-04-22 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, and Defibrillator, automatic (P050023/S146) | Biotronik, Inc. | 2020-04-22 |
| Activa Deep Brain Stimulation Therapy System (P960009/S372) | Medtronic, Inc. | 2020-04-22 |
| CERAMAX Ceramic Total Hip System (P070026/S071) | DePuy Orthopaedics, Inc. | 2020-04-22 |
| Defibrillator, implantable, dual-chamber (P000009/S085) | Biotronik, Inc. | 2020-04-22 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S004) | Defibtech, LLC | 2020-04-22 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S355) | Medtronic, Inc. | 2020-04-22 |
| Implantable System for Remodulin (P140032/S052) | Medtronic, Inc. | 2020-04-22 |
| Innova Self-Expanding Stent System (P140028/S058) | Boston Scientific Corporation | 2020-04-22 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S029) | Boston Scientific Corp | 2020-04-22 |
| Pulse Generator, Permanent, Implantable (P950037/S212) | Biotronik, Inc. | 2020-04-22 |
| Adapta, Versa, Sensia IPG, Advisa DR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, and Azure XT (P980035/S624) | Medtronic, Inc. | 2020-04-22 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Visia AF MRI DF1 IC (P980016/S737) | Medtronic Cardiac Rhythm Disease Management | 2020-04-22 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S101) | Biotronik, Inc. | 2020-04-22 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S459) | Medtronic Neuromodulation | 2020-04-22 |
| Revanesse Versa+ (P160042/S011) | Prollenium Medical Technologies, Inc. | 2020-04-21 |
| LIPOSORBER LA-15 System (P910018/S027) | Kaneka Pharma America Corp. | 2020-04-21 |
| Parvovirus B19 IgG Enzyme Immunoassay (P970054/S018) | Diasorin | 2020-04-21 |
| Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB) (P170003/S016) | Lutonix | 2020-04-21 |
| Parvovirus B19 IgM Enzyme Immunoassay (P970055/S020) | Diasorin | 2020-04-21 |
| LifeVest Wearable Defibrillator (P010030/S133) | Zoll Manufacturing Corporation | 2020-04-20 |
| Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) Rigid Gas Permeable Contact Lenses in Clear and Tin (P870024/S053) | CooperVision, Inc. | 2020-04-20 |
| Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S105) | CooperVision, Inc. | 2020-04-20 |
| Epic Vascular Self-Expanding Stent System (P110035/S059) | Boston Scientific Corp | 2020-04-20 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S030) | Boston Scientific Corp | 2020-04-20 |
| Innova Self-Expanding Stent System (P140028/S059) | Boston Scientific Corporation | 2020-04-20 |
| Frequency 55 (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P850079/S087) | CooperVision, Inc. | 2020-04-20 |
| Axonics Sacral Neuromodulation (SNM) System (P180046/S004) | Boston Scientific Corporation | 2020-04-19 |
| LifeVest Wearable Defibrillator (P010030/S134) | Zoll Manufacturing Corporation | 2020-04-18 |
| IPure Preloaded IOL System (P080004/S030) | Hoya Surgical Optics, Inc. | 2020-04-17 |
| Edwards Commander Delivery System, Edwards Certitude Delivery System (P140031/S113) | Edwards Lifesciences, LLC | 2020-04-17 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, and Spectra WaveWriter Spinal Co (P030017/S334) | Boston Scientific Corp | 2020-04-17 |
| FoundationOne CDx (F1CDx) (P170019/S013) | Foundation Medicine, Inc. | 2020-04-17 |
| IntellaNav MiFi Open-Irrigated Ablation Catheter (P150005/S049) | Boston Scientific Corp | 2020-04-17 |
| Automated Impella Controller (P140003/S070) | Abiomed, Inc. | 2020-04-17 |
| Innova Vascular Self-Expanding Stent System (P140028/S053) | Boston Scientific Corporation | 2020-04-16 |
| Mobi-C Cervical Disc Prosthesis (One-Level Indication) (P110002/S024) | Highridge Medical, LLC | 2020-04-16 |
| Biosense Webster Cables (P990071/S043) | Biosense Webster, Inc. | 2020-04-16 |
| EUFLEXXA (1% Sodium Hyaluronate) (P010029/S030) | Ferring Pharmaceuticals, Inc. | 2020-04-16 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S025) | Boston Scientific Corp | 2020-04-16 |
| Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, and Biosens (P010068/S059) | Biosense Webster, Inc. | 2020-04-16 |
| Amplatzer PFO Occluder (P120021/S015) | ABBOTT MEDICAL | 2020-04-16 |
| MiniMed 670G Insulin Pump (P160017/S082) | Medtronic Minimed, Inc. | 2020-04-16 |
| Micra AV Transcatheter Pacemaker System (P150033/S071) | Medtronic, Inc. | 2020-04-16 |
| Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, EZ St (P950005/S074) | Biosense Webster, Inc. | 2020-04-16 |
| MiniMed 630G Insulin Pump (P150001/S083) | Medtronic Minimed | 2020-04-16 |
| Amplatzer Muscular VSD Occluder (P040040/S040) | ABBOTT MEDICAL | 2020-04-16 |
| FlexAbility and FlexAbility SE Ablation Catheter (P110016/S068) | ABBOTT MEDICAL | 2020-04-16 |
| Mobi-C Cervical Disc Prosthesis (Two-Level Indication) (P110009/S024) | Highridge Medical, LLC | 2020-04-16 |
| LifeVest Wearable Defibrillator (P010030/S135) | Zoll Manufacturing Corporation | 2020-04-16 |
| Livewire TC Ablation Catheter and Safire Ablation Catheter (P960016/S081) | St Jude Medical | 2020-04-16 |
| Amplatzer Septal Occluder (P000039/S070) | ABBOTT MEDICAL | 2020-04-16 |
| EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Ca (P040036/S072) | Biosense Webster, Inc. | 2020-04-16 |
| Amplatzer Duct Occluder, Amplatzer Duct Occluder II, and Amplatzer Piccolo Occluder (P020024/S060) | ABBOTT MEDICAL | 2020-04-16 |
| HeartMate 3 (HM3) Left Ventricular Assist System (P160054/S028) | ABBOTT MEDICAL | 2020-04-16 |
| TactiCath Quartz Contact Force Ablation Catheter and TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S059) | St Jude Medical | 2020-04-16 |
| Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath (P030031/S104) | Biosense Webster, Inc. | 2020-04-16 |
| CentriMag Circulatory Support System (P170038/S003) | Abbott | 2020-04-16 |
| EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter, and Biosense Webster Cables (P990025/S059) | Biosense Webster, Inc. | 2020-04-16 |
| INGEVITY MRI Lead and INGEVITY non-MRI Lead (P150012/S093) | Boston Scientific | 2020-04-16 |
| Amplatzer PFO Occluder (P120021/S014) | ABBOTT MEDICAL | 2020-04-15 |
| COAPTITE Injectable Implant (P040047/S057) | Merz North America, Inc. | 2020-04-15 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolara CRT-P, Sol (P010015/S432) | Medtronic, Inc. | 2020-04-15 |
| Axonics Sacral Neuromodulation (SNM) System (P180046/S001) | Boston Scientific Corporation | 2020-04-15 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S D (P980035/S622) | Medtronic, Inc. | 2020-04-15 |
| RADIESSE Injectable Implant, RADIESSE Hands AND Radiesse (+) Lidocaine Demral Filler (P050052/S121) | Merz North America, Inc. | 2020-04-15 |
| Amplatzer Septal Occluder/Amplatzer Cribriform Occluder (P000039/S069) | ABBOTT MEDICAL | 2020-04-15 |
| PRESTIGE LP Cervical Disc (P090029/S014) | Medtronic Sofamor Danek USA, Inc. | 2020-04-15 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot (P980016/S735) | Medtronic Cardiac Rhythm Disease Management | 2020-04-15 |
| Amplatzer Muscular VSD Occluder (P040040/S039) | ABBOTT MEDICAL | 2020-04-15 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Compia MRI CRT-D, Compia MRI Q (P010031/S696) | Medtronic Cardiac Rhythm Disease Management | 2020-04-15 |
| RADIESSE Injectable Implant (P050037/S103) | Merz North America, Inc. | 2020-04-15 |
| Tack Endovascular System (6F) (P180034/S002) | Philips Image Guided Therapy Corporation | 2020-04-15 |
| Axonics Sacral Neuromodulation (SNM) System (P180046/S002) | Boston Scientific Corporation | 2020-04-15 |
| therascreen BRAF V600E RGQ PCR Kit (P190026) | QIAGEN GmbH | 2020-04-15 |
| Amplatzer Duct Occluder/Amplatzer Duct Occluder II/Amplatzer Piccolo Occluder (P020024/S059) | ABBOTT MEDICAL | 2020-04-15 |
| CardioMEMS HF System (P100045/S042) | ABBOTT MEDICAL | 2020-04-14 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot (P980016/S736) | Medtronic Cardiac Rhythm Disease Management | 2020-04-14 |
| SURGIFOAM Absorbable Gelatin Sponge, U.S.P. (P990004/S038) | Ferrosan Meidcal Devices A/S | 2020-04-14 |