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  6. 2019 Device Approvals
  1. Recently-Approved Devices

The products listed in this section include some of the newest medical technology from the year 2019. The products in each list contain information about what medical uses the device is cleared or approved for, when it can be used, and when it should not be used. This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.

Medical Devices Cleared or Approved by FDA in 2019


Device Name Category Date
CentriMag Circulatory Support System - P170038 Blood Pump 12/06/19
FoundationOne®CDx - P170019/S006 Laboratory Test 12/03/19
LIAISON QuantiFERON-TB Gold Plus, LIAISON Control QuantiFERON-TB Gold Plus, LIAISON QuantiFERON Software - P180047 Laboratory Test 11/26/19
Tula® System - P190016 Ear Tubes 11/25/19
IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter - P190008 Balloon Catheter 11/21/19
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear – P180035 Contact Lenses 11/15/19
Axonics Sacral Neuromodulation (SNM) System for Urinary Control – P180046 Urinary Retention 11/13/19
Myriad myChoice CDx - P190014 Laboratory Test 11/07/19
LIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control HCV Ab - P190011 Laboratory Test 10/18/19
iDESIGN® Refractive Studio and STAR S4 IR® Excimer Laser Systems – P930016/S057 Laser Vision Correction 09/09/19
Axonics Sacral Neuromodulation (SNM) System - P190006 Incontinence 09/06/19
Alcon Laboratories, Inc. AcrySof® IQ PanOptix® Trifocal Intraocular Lens (Model TFNT00) and AcrySof® IQ PanOptix® Toric Trifocal Intraocular Lens (Models TFNT30, TFNT40, TFNT50, TFNT60) - P040020/S087 Intraocular Lens 08/26/19
Minimally Invasive Deformity Correction (MID-C) System - H170001 Spine 08/23/19
BAROSTIM NEO System - P180050 Heart Failure 08/16/19
The Tether™ - Vertebral Body Tethering System - H190005 Spine 08/16/19
Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System - P130021/S058 Heart Valve 08/16/19
Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System - P140031/S085 Heart Valve 08/16/19
PD-L1 IHC 22C3 pharmDx - P150013/S016 Laboratory Test 07/30/19
MED-EL Cochlear Implant System - P000025/S104 Cochlear Implant 07/19/19
Medtronic CoreValve System; Medtronic CoreValve Evolut R System; Medtronic CoreValve Evolut PRO System - P130021/S033 Heart Valve 07/10/19
PD-L1 IHC 22C3 pharmDx - P150013/S014 Laboratory Test 06/10/19
HeartStart OnSite Defibrillator (Model M5066A), HeartStart Home Defibrillator (Model M5068A), Primary Battery (Model M5070A), SMART Pads Cartridges (Adult Model M5071A) and Infant/Child (Model M5072A) - P160029 Defibrillator 06/06/19
Eversense Continuous Glucose Monitoring System - P160048/S006 Glucose Monitor 06/06/19
Hintermann Series H3™ Total Ankle Replacement System - P160036 Joint Replacement 06/04/19
TransMedics OCS Lung System - P160013/S002 Lung Donor 05/31/19
The therascreen PIK3CA RGQ PCR Kit - P190001 and P190004 Cancer 05/24/19
NovoTTF™-100L System - H180002 Cancer 05/23/19
Neuroform Atlas® Stent System - P180031 Stent 05/16/19
VICI VENOUS STENT® System - P180013 Stent 05/02/19
Tack Endovascular System® (6F) - P180034 Vascular 05/01/19
XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate - P180014 Perfusion System 04/26/19
LOTUS Edge™ Valve System - P180029 Heart Valve 04/23/19
TransPyloric Shuttle/TransPyloric Shuttle Delivery Device - P180024 Weight Loss 04/16/19
therascreen® FGFR RGQ PCR Kit – P180043 Laboratory Test 04/12/19
TherOx DownStream System - P170027 Oxygen Therapy 04/02/19
Cerene Cryotherapy Device - P180032 Menstrual Bleeding 03/28/19
TRILURON™ - P180040 Osteoarthritis 03/16/19
OPTIMIZER Smart System - P180036 Cardiovascular 03/21/19
MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System - P100009/S028 Vascular 03/14/19
VENOVO Venous Stent System - P180037 Stent 03/13/19
Barricaid® Anular Closure Device (ACD) - P160050 Cancer 03/11/19
COVERA™ Vascular Covered Stent - P170042/S002 Stent 03/01/19
VENTANA PD-L1 (SP142) Assay - P160002/S009 Hernia 02/08/19
M6-C™ Artificial Cervical Disc - P170036 Spine 02/06/19
MANTA Vascular Closure Device - P180025 Vascular 02/01/19
Sangia Total PSA Test - P170037 Prostate Cancer 01/30/19

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