| Vercise™ PC and Vercise Gevia™ Deep Brain Stimulation (DBS) System - P150031/S028 |
Implantable Pulse Generator |
12/29/20 |
| MiniMed 770G System - P160017/S076 |
Glucose Monitor |
12/23/20 |
| Gore® Excluder® Conformable AAA Endoprosthesis - P200030 |
Catheter |
12/22/20 |
| Osseonachored Prostheses for Rehabiliation of Amputees (OPRA)TM Implant System - P190009 |
Implant |
12/18/20 |
| ActaStim-S Spine Fusion Stimulator - P190030 |
Bone Growth Stimulator |
12/09/20 |
| Plasma Delipidation System (PDS-2™ System) - H190001 |
Plasma Plaque Reducer |
12/01/20 |
| Sonalleve MR-HIFU - H190003 |
High Intensity Ultrasound |
11/27/20 |
| FoundationOne® CDx - P170019/S017 |
Laboratory Test |
11/23/20 |
| Oncomine™ Dx Target Test - P160045/S019 |
Laboratory Test |
11/23/20 |
| FoundationOne Liquid CDx - P200016 |
Laboratory Test |
11/06/20 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter - P190019 |
Catheter |
10/30/20 |
| Abre Venous Self-expanding Stent System - P200026 |
Stent |
10/21/20 |
| Zilver Vena Venous Self-Expanding Stent - P200023 |
Stent |
10/09/20 |
| THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter - P030031/S100 |
Catheter |
09/30/20 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System – P160043/S034 |
Stent |
09/22/20 |
| Revanesse® Lips+ - P160042/S010 |
Dermal Filler |
09/21/20 |
| Simplify Cervical Artificial Disc - P200022 |
Cervical Implant |
09/18/20 |
| Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System - P140031/S112 |
Valve Implant |
09/09/20 |
| Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent – P200015/S011 |
Stent |
08/31/20 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System - P200015 |
Heart Valve |
08/31/20 |
| LIAISON XL MUREX HBsAg Confirmatory test, LIAISON® XL MUREX Control HBsAg, LIAISON® XL MUREX Qual HBsAg - P190017 |
HBsAg Confirmatory Test |
08/29/20 |
| LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg - P180048 |
Laboratory Test |
08/29/20 |
| LIAISON® XL MUREX HBc IgM, LIAISON® MUREX Control HBc IgM - P180045 |
Laboratory Test |
08/29/20 |
| Alinity m HBV - P200013 |
Laboratory Test |
08/29/20 |
| LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe - P180049 |
Laboratory Test |
08/29/20 |
| FoundationOne Liquid CDx - P190032 |
Laboratory Test |
08/26/20 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) - P15003/S058 |
Stent |
08/11/20 |
| Kendall™ Multifunction Defibrillation Electrodes - P190007 |
Automated External Defibrillator (AED) |
08/07/20 |
| Guardant360 CDx - P200010 |
Laboratory Test |
08/07/20 |
| Neuroform Atlas® Stent System - P180031/S001 |
Stent |
07/30/20 |
| VENTANA HER2 Dual ISH DNA Probe Cocktail - P190031 |
Laboratory Test |
07/28/20 |
| WATCHMAN Left Atrial Appendage Closure Device with Delivery System and WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System - P130013/S035 |
Stent |
07/21/20 |
| The Arctic Front Advance™ and Arctic Front Advance Pro™ and The Freezor Max™ Cardiac Cryoablation Catheters - P100010/S098 |
Catheter |
06/23/20 |
| cobas® EZH2 Mutation Test - P200014 |
Laboratory Test |
06/18/20 |
| Reactiv8 Implantable Neurostimulation System - P190021 |
Implantable Neurostimulation System |
06/16/20 |
| FoundationOne®CDx - P170019/S016 |
Laboratory Test |
06/16/20 |
| JUVÉDERM® VOLUMA™ XC - P110033/S047 |
Dermal Filler |
06/12/20 |
| PD-L1 IHC 28-8 pharmDx - P150025/S013 |
Laboratory Test |
06/08/20 |
| FoundationOne CDx - P170019/S015 |
Laboratory Test |
05/19/20 |
| HeartStart FRx Defibrillator (861304), Primary Battery (Model M5070A), Aviation FRx Battery (989803139301), SMART Pads II (Model 989803139261), and Infant/Child Key (Model 989803139311) - P180028 |
Automated External Defibrillator (AED) |
05/11/20 |
| Philips HeartStart FR3 Defibrillator, Primary Battery, Rechargeable Battery, Charger for the Rechargeable Battery, SmartPads III, DP pads, and Pediatric Key - P160028 |
Automated External Defibrillator (AED) |
05/11/20 |
| FoundationOne CDx - P170019/S011 |
Laboratory Test |
05/06/20 |
| TREO® Abdominal Stent-Graft System - P190015 |
Stent |
05/04/20 |
| FoundationOne CDx - P170019/S013 |
Laboratory Test |
04/17/20 |
| The therascreen® BRAF V600E RGQ PCR Kit - P190026 |
Laboratory Test |
04/15/20 |
| Inspire® Upper Airway Stimulation - P130008/S039 |
Implantable Nerve Stimulator |
04/14/20 |
| Tack Endovascular System® (4F, 1.5-4.5mm) - P190027 |
Vascular Patch |
04/10/20 |
| The prodisc® L Total Disc Replacement - P050010/S020 |
Disc Replacement |
04/10/20 |
| The cobas HPV for use on the cobas 6800/8800 Systems - P190028 |
Laboratory Test |
04/03/20 |
| Restylane® Kysse - P140029/S021 |
Gel Implant |
03/26/20 |
| Alinity m HCV - P190025 |
Laboratory Test |
03/23/20 |
| LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs, LIAISON® XL MUREX Anti-HBs Verifiers - P180039 |
Hepatitis B (HBV) |
03/18/20 |
| VENOUS WALLSTENT - P980033/S050 |
Stent |
03/17/20 |
| Nucleus 24 Cochlear Implant System - P970051/S172 |
Cochlear Implant |
03/17/20 |
| Alto™ Abdominal Stent Graft System - P120006/S031 |
Stent |
03/13/20 |
| Ventana Medical Systems CINtec PLUS Cytology - P190024 |
Laboratory Test |
03/10/20 |
| AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (IOL) (Model DFT015), AcrySof™ IQ Vivity™ Toric Extended Vision IOLs (DFT315, DFT415, DFT515), AcrySof™ IQ Vivity™ Extended Vision UV Absorbing IOL (DAT015), and AcrySof™ IQ Vivity™ Toric Extended Vision UV Absorbing IOLs (DAT315, DAT415, DAT515) - P930014/S126 |
Intraocular Lens (IOL) |
02/26/20 |
| PyloPlus UBT System - P170022 |
Laboratory Test |
02/18/20 |
| Bulkamid Urethral Bulking System - P170023 |
Incontinence |
02/14/20 |
| Flow Re-Direction Endoluminal Device (FRED®) System - P180027 |
Stent |
01/22/20 |
| Abbott InfinityTM DBS Neurostimulation System - P140009/Abbott InfinityTM DBS Neurostimulation System - P140009/S039 |
Neurostimulation System |
01/20/20 |
| Clareon Aspheric IOL, Clareon Toric Aspheric IOL, Clareon Aspheric IOL, AutonoMe System, Clareon Toric IOL, AutonoMe System - P190018 |
Intraocular Lens (IOL) |
01/07/20 |
| LIAISON® XL MUREX Anti-HBc, LIAISON® XL MUREX Control Anti-HBc - P180038 |
Blood Assay |
01/02/20 |
