Medical Devices

2015 Device Approvals

The products listed in this section include some of the newest medical technology from the year 2015. 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 2015

Device NameCategoryDate
LifeVest Wearable Cardioverter Defibrillator - P010030/S056 Wearable Cardioverter Defibrillator 12/17/15
Edwards SAPIEN XT Transcatheter Heart Valve - P130009/S034 Heart valve 10/09/15
Cobas® HBV – P150014 Lab test 10/14/15
cobas®HCV Test – P150015 HCV Test 10/14/15
PD-L1 IHC 28-8 pharmDx – P150025 Cancer Test 10/08/15
ORBERA™ Intragastric Balloon System - P140008 Gastric Balloons 08/05/15
ReShape Integrated Dual Balloon System - P140012 Gastric Balloons 07/28/15
Innova Vascular Self-Expanding Stent System - P140028 Stent 07/21/15
Restylane Lyft with Lidocaine Injectable Gel Injectable Dermal Filler - P040024/S073 Dermal Filler 07/01/15
Edwards SAPIEN 3 Transcatheter Heart Valve - P140031 Transcatheter Heart Valve 06/17/15
VENTANA ALK (D5F3) CDx Assay - P140025 Cancer Test 06/12/15
activL® Artificial Disc - P120024 Spinal Implant 06/11/15
Elecsys® Anti-HCV II Immunoassay and Elecsys® PreciControl Anti-HCV - P140021 HCV Test 06/11/15
Radiesse Injectable Implant - P050052/S049 Dermal Filler 06/04/15
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire), and Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) - P110010/S096 Coronary Stent System 06/01/15
Superion InterSpinous Spacer - P140004 Spinal Implant 05/20/15
Misago Peripheral Stent System - P140002 Stents 05/22/15
Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System - P120005/S031 Glucose Sensor 05/22/15
ENROUTE Transcarotid Stent System – P140026 Stent System 05/18/15
Senza Spinal Cord Stimulation (SCS) System - P130022 Spinal cord stimulation system 05/08/15
cobas KRAS Mutation Test - P140023 Colorectal Cancer 05/07/15
STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System – P930016/S044 Laser System 05/06/15
Myopore Sutureless Myocardial Pacing Lead - P130012 Heart Implant 04/30/15
Model 5071 Lead - P120017 Heart Implant 04/27/15
MAMMOMAT Inspiration with Tomosynthesis - P140011 Mammography 04/21/15
KAMRA Inlay - P120023 Cornea Implant 04/17/15
AcrySof IQ ReSTOR 2.5 D Multifocal Intraocular Lens (IOL), Model SV25T0 - P040020/S050 Intraocular Lens 04/13/15
Gastric Emptying Breath Test (GEBT) - P110015 Gastroparesis 04/06/15
Adherus AutoSpray Dural Sealant - P130014 Brain Surgery 03/30/15
Medtronic CoreValve System - P130021/S010 Transcatheter Aortic Valve 03/30/15
Impella 2.5 System - P140003 Heart Pump 03/23/15
WATCHMAN LAA Closure Technology - P130013 Atrial Fibrillation 03/13/15
ResQCPR System: ResQPump (ACD-CPR device) and ResQPOD ITD 16 - P110024 Cardiac Arrest 03/06/15
Lixelle Beta 2-microglobulin Apheresis Column - H130001 Kidney Dialysis 03/05/15
VenaSeal Closure System - P140018 Varicose Veins 02/20/15
Progel Pleural Air Leak Sealant - P010047/S036 Surgical Sealant 02/13/15
TissuGlu Surgical Adhesive - P130023 Surgical Adhesive 02/03/15
Melody Transcatheter Pulmonary Valve - P140017 Heart Valve 01/27/15
Impella RP System - H140001 Heart Pump 01/23/15
Protégé GPS Self-Expanding Peripheral Stent System - P060001/S020 Stent 01/21/15
Koning Breast CT - P130025 Computed Tomography 01/14/15
EnteroMedics Maestro Rechargeable System - P130019 Obesity 01/14/15

Page Last Updated: 12/17/2015
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